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Stop using now Medical device recall · FDA · Published November 3, 2022

DeRoyal MYELOGRAM PACK Recall: Risk of Fire in Normal Use

DeRoyal recalls MYELOGRAM PACK model REF 89-9304.05 with specific lot numbers due to fire risk in normal use. Affected units may need immediate action.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0647-2023Medical deviceDeRoyal ›
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Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703
✎ GovInfoNow plain-language explainer

DeRoyal is recalling specific MYELOGRAM PACK products with lot numbers 55612944, 56615881, 56279557, 57185350, and 57591593. These packs could overheat and cause fire during normal use, so affected owners should stop using them immediately. Read more at govinfonow.com/recall/59499-deroyal-myelogram-pack-recall-risk-of-fire-in-normal-use.

Source Summary by GovInfoNow · govinfonow.com/recall/59499-deroyal-myelogram-pack-recall-risk-of-fire-in-normal-use · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0647-2023

Cite this page

“DeRoyal MYELOGRAM PACK Recall: Risk of Fire in Normal Use.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/59499-deroyal-myelogram-pack-recall-risk-of-fire-in-normal-use. Based on FDA recall #Z-0647-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0647-2023%22&limit=1).

The FDA announced on 2022-11-03 that DeRoyal Industries Inc is recalling the DeRoyal MYELOGRAM PACK, REF 89-9304.05. The company initiated this voluntary Class II recall.

How to tell if you have it

  • Brand: DeRoyal
  • Product: DeRoyal MYELOGRAM PACK, REF 89-9304.05
  • Lot Numbers: 55612944 exp 3/1/2026; 56615881 exp 7/1/2026; 56279557 exp 5/1/2026; 57185350 exp7/1/2026; 57591593 exp 1/1/2025
  • Units affected: 2280 kits

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since 2017-06-07. Other recent recalls include the DeRoyal Myocardial Probe Recall (2026-08-20), the DeRoyal Covaderm Plus Dressing Recall (2026-05-18), and the DeRoyal Suction Tubing Recall (2025-01-31). Other recent recalls of similar products include the Medline Full Electric Low Bed Recall (2025-11-26), the Medline Semi Electric Lightweight Bed Recall (2025-11-26), and the Medline beds recall (2025-11-26).

How to tell if you have this one

Check the lot number on your DeRoyal MYELOGRAM PACK. The affected lots are 55612944 (expires 3/1/2026), 56615881 (expires 7/1/2026), 56279557 (expires 5/1/2026), 57185350 (expires 7/1/2026), and 57591593 (expires 1/1/2025).

  • Brand
    DeRoyal
  • Category
    Medical device
FDA recall event · 156 products

All 156 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
Recall numberProduct, codes & lotsQuantity
Z-0560-2023DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15; Lot 57589637, exp 6/1/202378 kits
Z-0561-2023DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15; Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024828 kits
Z-0562-2023DeRoyal EYE PACK, REF 89-4051.09; Lot Numbers: Lot 56778647 exp 4/1/2023; Lot 57190263 exp 4/1/2023; Lot 57750460 exp 4/3/2023156 kits
Z-0563-2023DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07; Lot Numbers: Lot 56394918 exp 11/3/2024; Lot 56778591 exp 12/1/2024130 kits
Z-0564-2023DeRoyal EYE TRAY, REF 89-4957.08; Lot Numbers: Lot 55646968 exp 6/1/202348 kits
Z-0565-2023DeRoyal PEDI ORTHO PACK, REF 89-5323.20; Lot Numbers: Lot 56181816 exp 10/1/202327 kits
Z-0566-2023GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07; Lot Numbers: Lot 56822290 exp 2/1/20254 units
Z-0567-2023GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13; Lot Numbers: Lot 56184443 exp 5/1/2023; Lot 56618408 exp 1/1/2023; Lot 57589531 exp 12/1/202379 units
Z-0568-2023GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09; Lot Numbers: Lot 56392226 exp 9/1/2023; Lot 56683525 exp 9/1/2023; Lot 57001506 exp 4/1/2024135 kits
Z-0569-2023DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13; Lot Numbers: Lot 56005273 exp 5/1/2024; Lot 56657845 exp 5/1/2024; Lot 57021523 exp 8/1/2024; Lot 57392244 exp 8/1/2024; Lot 57770575 exp 3/1/2025918 kits
Z-0570-2023GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05; Lot Numbers: Lot 56073866 exp 12/1/2023; Lot 56618070 exp 10/1/2024; Lot 57001434 exp 2/1/2025; Lot 57392105 exp 2/3/2025184 kits
Z-0571-2023GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08; Lot Numbers: Lot 56065591 exp 8/1/1024; Lot 56618230 exp 9/1/202490 kits
Z-0572-2023GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09; Lot Numbers: Lot 57709678 exp 10/1/202430 kits
Z-0573-2023DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09; Lot Numbers: Lot 56391741 exp 1/1/2023; Lot 56617587 exp 2/1/2025; Lot 57391604 exp 1/1/2024144 kits
Z-0574-2023DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07; Lot Numbers: Lot 56391733 exp 3/1/20243 kits
Z-0575-2023DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09; Lot Numbers: Lot 57391516 exp 11/1/2024; Lot 57749549 exp 8/1/202442 kits
Z-0576-2023GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09; Lot Numbers: Lot 56073840 exp 8/1/2022; Lot 56617675 exp 4/21/2023; Lot 57001291 exp 1/1/2023165 kits
Z-0577-2023GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10; Lot Numbers: Lot 57391655 exp 6/1/2023; Lot 57895706 exp 6/1/2023102 kits
Z-0578-2023GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02; Lot Numbers: Lot 55441428 exp 7/1/2023; Lot 55966742 exp 10/1/2023; Lot 56777898 exp 12/1/2023; Lot 57391081 exp 2/1/2024; Lot 57748071 exp 2/1/202449 kits
Z-0579-2023DeRoyal SHOULDER PACK, REF 89-6830.13; Lot Numbers: Lot 56184005 exp 11/1/2023; Lot 56254392 exp 10/1/2023; Lot 56777927 exp 1/1/2024; Lot 57391031 exp 2/1/2024; Lot 57684204 exp 5/1/2024876 kits
Z-0580-2023DeRoyal CATARACT PACK CSM, REF 89-6863; Lot Numbers: Lot 55807995 exp 1/1/2023; lot 56029890 exp ***; lot 57001098 exp ***; lot 57198118 exp ***; lot 56613261 exp ***1220 kits
Z-0581-2023DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09; Lot Numbers: Lot 56183862 exp 3/1/2025; Lot 56613244 exp 9/1/2025108 kits
Z-0582-2023DeRoyal CANNULTED HIP PACK, REF 89-6977.10; Lot Numbers: Lot 57198177 exp 4/1/202536 kits
Z-0583-2023DeRoyal BREAST TRAY, REF 89-7033.07; Lot Numbers: Lot 56390335 exp 1/1/2024; Lot 57001021 exp 1/1/2024162 kits
Z-0584-2023DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11; Lot Numbers: Lot 57085711 exp 9/1/202530 kits
Z-0585-2023DeRoyal GU ROBOTIC PACK, REF 89-7063.12; Lot Numbers: Lot 57387066 exp 9/1/2026192 kits
Z-0586-2023DeRoyal CATARACT PACK, REF 89-7135.10; Lot Numbers: Lot 57312291 exp 12/1/2024; Lot 57500604 exp ***; Lot 56043472 exp ***; Lot 57894789 exp ***190 kits
Z-0587-2023DeRoyal TRANS CANAL PACK, REF 89-7157.12; Lot Numbers: Lot 57029630 exp 8/1/2024; Lot 57387111 exp 6/1/2026; Lot 57894800 exp ***156 kits
Z-0588-2023DeRoyal LAPINECTOMY PACK, REF 89-7198.10; Lot Numbers: Lot 56612971 exp 7/1/2026; Lot 56802580 exp 7/1/2026403 kits
Z-0589-2023DeRoyal LAPINECTOMY PACK, REF 89-7198.11; Lot Numbers: Lot 57091046 exp 7/1/2026; Lot 57224911 exp 5/1/2026; Lot 57387648 exp 8/1/2026; Lot 57748491 exp 10/1/2026715 kits
Z-0590-2023DeRoyal BASIC NEURO PACK, REF 89-7258.10; Lot Numbers: Lot 56777564 exp 5/1/2026108 kits
Z-0591-2023DeRoyal BASIC NEURO PACK, REF 89-7258.12; Lot Numbers: Lot 57287655 exp 9/1/202696 kits
Z-0592-2023DeRoyal BASIC NEURO PACK, REF 89-7258.13; Lot Numbers: Lot 57748706 exp 11/1/2026216 kits
Z-0593-2023DeRoyal VIT RD PACK 86ST, REF 89-7308.09; Lot Numbers: Lot 57784627 exp 4/1/2025; Lot 57974922 exp ***16 kits
Z-0594-2023DeRoyal RETINAL PACK, REF 89-7336.07; Lot Numbers: Lot 57000221 exp 9/1/2024; Lot 57413324 exp 12/1/202464 kits
Z-0595-2023DeRoyal CUSTOM NEURO PACK, REF 89-7353.17; Lot Numbers: Lot 57678322 exp 11/1/202636 kis
Z-0596-2023DeRoyal SPINAL FUSION PACK, REF 89-7515.12; Lot Numbers: Lot 56254211 exp 6/1/2026; Lot 56841212 exp 9/1/202627 kits
Z-0597-2023DeRoyal SPINAL FUSION PACK, REF 89-7515.13; Lot Numbers: Lot 57197182 exp 2/1/202616 kits
Z-0598-2023DeRoyal SPINAL FUSION PACK, REF 89-7515.14; Lot Numbers: Lot 57746997 exp 12/1/202630 kits
Z-0599-2023DeRoyal BASIC NEURO PACK, REF 89-7523.15; Lot Numbers: Lot 56611821 exp 8/1/2026; Lot 56881417 exp 9/1/2026288 kits
Z-0600-2023DeRoyal BASIC NEURO PACK, REF 89-7523.16; Lot Numbers: Lot 57227388 exp 5/1/2026; Lot 57466371 exp 11/1/2026304 kits
Z-0601-2023DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09; Lot Numbers: Lot 57197297 exp 3/1/1024; Lot 57746479 exp 5/1/2024264 kits
Z-0602-2023DeRoyal ENDOVENOUS PACK, REF 89-7762.05; Lot Numbers: Lot 54880154 exp 12/1/2023; Lot 57186299 exp 10/1/202488 kits
Z-0603-2023DeRoyal EYE TRAY PGYBK, REF 89-7978.02; Lot Numbers: Lot 56394686 exp 7/1/2024180 kits
Z-0604-2023GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02; Lot Numbers: Lot 56440662 exp 10/1/2024; Lot 56618491 exp 11/1/202448 kits
Z-0605-2023GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02; Lot Numbers: Lot 56189375 exp 10/1/2024; Lot 56392381 exp 10/1/2024; Lot 56618504 exp 11/1/2024; Lot 57392455 exp 2/1/2025; Lot 5775963 exp 4/1/2025243 kits
Z-0606-2023DeRoyal BASIC EYE PACK, REF 89-8337.08; Lot Numbers: Lot 56386740 exp 8/1/2024; Lot 55970688 exp 08/01/202445 kits
Z-0607-2023DeRoyal BASIC EYE PACK, REF 89-8337.09; Lot Numbers: Lot 57118632 exp 9/1/2024; Lot 57184285 exp 12/1/2024; Lot 57630628 exp 4/1/2025; Lot 57745978 exp 4/1/2025: Lot 57688413 exp 12/01/202450 kits
Z-0608-2023DeRoyal HEART PACK, REF 89-8351.11; Lot Numbers: Lot 56189105 exp 9/1/2024; Lot 57005558 exp 9/1/2024240 kits
Z-0609-2023DeRoyal HEART PACK, REF 89-8351.12; Lot Numbers: Lot 57367401 exp 3/1/2025102 kits
Z-0610-2023DeRoyal HEART PACK, REF 89-8351.13; Lot Numbers: Lot 57893436 exp 9/1/202451 kits
Z-0611-2023DeRoyal PODIATRY PACK, REF 89-8359.10; Lot Numbers: Lot 56705544 exp 6/1/2026186 kits
Z-0612-2023DeRoyal PODIATRY PACK, REF 89-8359.13; Lot Numbers: Lot 57593741 exp 1/1/2027102 kits
Z-0613-2023DeRoyal SPINE PACK, REF 89-8361.08; Lot Numbers: Lot 56189228 exp 4/1/2026; Lot 56614415 exp 2/1/2026243 kits
Z-0614-2023DeRoyal SPINE PACK, REF 89-8361.09; Lot Numbers: Lot 57005620 exp 09/01/2026144 kits
Z-0615-2023DeRoyal SPINE PACK, REF 89-8361.10; Lot Numbers: Lot 57745943 exp 12/1/202696 kits
Z-0616-2023DeRoyal CUSTOM NEURO PACK, REF 89-8392.09; Lot Numbers: Lot 56614271 exp 4/1/202612 kits
Z-0617-2023DeRoyal CUSTOM NEURO PACK, REF 89-8392.10; Lot Numbers: Lot 57745880 exp 12/1/202612 kits
Z-0618-2023DeRoyal BASIC PACK, REF 89-8633.07; Lot Numbers: Lot 56188938 exp 6/1/2024; Lot 57022930 exp 6/1/2024; Lot 57825222 exp 6/1/2024130 kits
Z-0619-2023GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01; Lot Numbers: Lot 56618256 exp 3/1/2024; Lot 57005427 exp 11/1/202476 kits
Z-0620-2023GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02; Lot Numbers: Lot 57745716 exp 10/1/202416 kits
Z-0621-2023DeRoyal PORT PACK PGYBK, REF 89-8748.05; Lot Numbers: Lot 56250480 exp 9/1/2024; Lot 57391954 exp 10/1/2024240 kits
Z-0622-2023GEO-MED BIOPSY TRAY, REF 89-8753.01; Lot Numbers: Lot 56005548 exp 6/1/2023; Lot 57005363 exp 7/1/2023460 units
Z-0623-2023DeRoyal EYE PACK, REF 89-8756.03; Lot Numbers: Lot 57344921 exp 11/1/202672 kits
Z-0624-2023DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04; Lot Numbers: Lot 56781336 exp 11/1/2024; Lot 56882647 exp 10/1/2024100 kits
Z-0625-2023DeRoyal ACDF PACK, REF 89-8779.03; Lot Numbers: Lot 56188891 exp12/1/2023; Lot 56675066 exp 7/1/202345 kits
Z-0626-2023DeRoyal TLIF PACK, REF 89-8780.04; Lot Numbers: Lot 56020431 exp 9/1/2023; Lot 56390757 exp 1/1/202464 kits
Z-0627-2023DeRoyal KIT TOTAL HIP, REF 89-8861.07; Lot Numbers: Lot 56390773 exp 6/1/2026; Lot 56617464 exp 6/1/2026; Lot 57085981 exp 10/1/2026146 kits
Z-0628-2023DeRoyal KIT EXTREMITY PACK, REF 89-8869.09; Lot Numbers: Lot 56390950 exp 6/1/2026; Lot 56837871 exp 9/1/2026; Lot 5718781 exp 10/1/202675 kits
Z-0629-2023DeRoyal KIT HEART B PACK, REF 89-9042.07; Lot Numbers: Lot 56613762 exp 6/1/202668 kits
Z-0630-2023DeRoyal KIT HEART B PACK, REF 89-9042.08; Lot Numbers: Lot 57388270 exp 8/1/202668 kits
Z-0631-2023DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08; Lot Numbers: Lot 56066279 exp 6/1/2024; Lot 56631186 exp 6/1/2024180 kits
Z-0632-2023DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09; Lot Numbers: Lot 56973098 exp 6/1/202490 kits
Z-0633-2023DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10; Lot Numbers: Lot 57757928 exp 9/1/2024100 kits
Z-0634-2023DeRoyal TOTAL HIP PACK, REF 89-9113.06; Lot Numbers: Lot 56042728 exp 5/1/202616 kits
Z-0635-2023DeRoyal TOTAL HIP PACK, REF 89-9113.07; Lot Numbers: Lot 57460930 exp 2/1/20268 kits
Z-0636-2023DeRoyal BASIC EYE PACK, REF 89-9233.08; Lot Numbers: Lot 57389942 exp 9/1/202460 kits
Z-0637-2023DeRoyal MAJOR ORTHO PACK, REF 89-9250.07; Lot Numbers: Lot 56388551 exp 10/1/2024; Lot 56780333 exp 3/1/202548 kits
Z-0638-2023DeRoyal FOOT PACK, REF 89-9252.06; Lot Numbers: Lot 56005476 exp 8/1/2024; Lot 56389449 exp 1/1/2025350 kits
Z-0639-2023DeRoyal FOOT PACK, REF 89-9252.07; Lot Numbers: Lot 57171601 exp 10/1/2024; Lot 57505843 exp 1/1/2025217 kits
Z-0640-2023DeRoyal FOOT PACK, REF 89-9252.08; Lot Numbers: Lot 57899862 exp 3/1/2025105 kits
Z-0641-2023DeRoyal NEURO PACK, REF 89-9253.07; Lot Numbers: Lot 56389334 exp 3/1/2025; Lot 56615629 exp 3/1/2025; Lot 57003940 exp 3/1/202593 kits
Z-0642-2023DeRoyal NEURO PACK, REF 89-9253.09; Lot Numbers: Lot 57760211 exp 3/1/202545 kits
Z-0643-2023DeRoyal BIOPSY PACK, REF 89-9270.04; Lot Numbers: Lot 56094211 exp 5/1/2024560 kits
Z-0644-2023DeRoyal BIOPSY PACK, REF 89-9270.05; Lot Numbers: Lot 57119598 exp 8/1/2024; Lot 57754111 exp 10/1/20241200 kits
Z-0645-2023DeRoyal TOTAL KNEE PACK, REF 89-9300.08; Lot Numbers: Lot 57198935 exp 6/1/202448 kits
Z-0646-2023DeRoyal TOTAL HIP PACK, REF 89-9301.07; Lot Numbers: Lot 56186932 exp 2/1/2025; Lot 57091222 exp 3/1/202585 kits
Z-0647-2023DeRoyal MYELOGRAM PACK, REF 89-9304.05; Lot Numbers: Lot 55612944 exp 3/1/2026; Lot 56615881 exp 7/1/2026; Lot 56279557 exp 5/1/2026; Lot 57185350 exp7/1/2026; Lot 57591593 exp 1/1/20252280 kits
Z-0648-2023DeRoyal MYELOGRAM PACK, REF 89-9304.06; Lot Numbers: Lot 57913388 exp 12/1/2026480 kits
Z-0649-2023DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03; Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2024; Lot 57190141 exp 10/1/2024; Lot 57754751 exp 1/1/2025495 kits
Z-0650-2023DeRoyal SHOULDER PACK, REF 89-9449.12; Lot Numbers: Lot 56616218 exp 12/1/202432 kits
Z-0651-2023DeRoyal SHOULDER PACK, REF 89-9449.13; Lot Numbers: Lot 57755295 exp 4/1/202548 kits
Z-0652-2023DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12; Lot Numbers: Lot 55969791 exp 5/1/2024; Lot 56755349 exp 6/1/202518 kits
Z-0653-2023DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13; Lot Numbers: Lot 57199372 exp 6/1/20256 kits
Z-0654-2023DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14; Lot Numbers: Lot 57754971 exp 1/1/202518 kits
Z-0655-2023DeRoyal SHOULDER KIT, REF 89-9497.08; Lot Numbers: Lot 56580884 exp 12/1/202414 kits
Z-0656-2023DeRoyal SHOULDER KIT, REF 89-9497.10; Lot Numbers: Lot 576900006 exp 4/1/2025; Lot 57770532 exp 4/1/202528 kits
Z-0657-2023DeRoyal TOTAL HIP KIT, REF 89-9498.08; Lot Numbers: Lot 56187960 exp 12/4/2024; Lot 57031051 exp 3/1/202551 kits
Z-0658-2023DeRoyal TOTAL HIP KIT, REF 89-9498.10; Lot Numbers: Lot 57686947 exp 5/1/202545 kits
Z-0659-2023DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11; Lot Numbers: Lot 56388673 exp 6/1/2026; Lot 56842522 exp 6/1/2026; Lot 57271485 exp 9/1/2026; Lot 57512154 exp 11/1/2026360 kits
Z-0660-2023DeRoyal ABDOMINOPLASTY W/LIPO PACK, REF 89-9557.03; Lot Numbers: Lot 55862118 exp 6/1/2023; Lot 56394942 exp 6/1/2023; Lot 57004352 exp 9/1/2023; Lot 57686883 exp 10/1/2023438 kits
Z-0661-2023DeRoyal UNIVERSAL PACK, REF 89-9558.03; Lot Numbers: Lot 56187476 exp 12/1/2026; Lot 57190116 exp 4/1/202775 kits
Z-0662-2023DeRoyal BIOPSY PACK, REF 89-9614.07; Lot Numbers: Lot 56584885 exp 9/1/2024, Lot 57030745 exp 2/1/2025, Lot 57686461 exp 5/1/2025480 units
Z-0663-2023DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05; Lot Numbers: Lot 55968916 exp 7/1/2023; Lot 56620786 exp7/1/2023; Lot 56780667 exp 7/1/202370 kits
Z-0664-2023DeRoyal BIOPSY PACK, REF 89-9739.05; Lot Numbers: Lot 56842514 exp 8/1/2026180 kits
Z-0665-2023DeRoyal BIOPSY PACK, REF 89-9739.06; Lot Numbers: Lot 57686568 exp 3/1/2027360 kits
Z-0666-2023DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04; Lot Numbers: Lot 56394580 exp 10/1/2024; Lot 56780181 exp12/1/2024; Lot 56822791 exp 11/1/2024363 kits
Z-0667-2023DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06; Lot Numbers: Lot 56186481 exp 11/1/2023; Lot 56431109 exp 1/1/2024; Lot 57189203 exp 6/1/202463 kits
Z-0668-2023DeRoyal FACIAL PACK PGYBK, REF 89-10007.03; Lot Numbers: Lot 55968449 exp 1/1/2024; Lot 56619751 exp 4/1/202435 kits
Z-0669-2023DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02; Lot Numbers: Lot 57288181 exp 2/1/2024; Lot 56665247 exp 9/1/2023N/A
Z-0670-2023DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02; Lot Numbers: Lot 56395179 exp 12/1/2023; Lot 56431133 exp 9/1/2023; Lot 57190554 exp 3/1/2024; Lot 5740754 exp 4/1/2024N/A
Z-0671-2023DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10061.02; Lot Numbers: Lot 55972430 exp 10/1/2022; Lot 56621455 exp 11/1/2023; Lot 57302780 exp 2/1/2024N/A
Z-0672-2023DeRoyal TOTAL SHOULDER PACK, REF 89-10151.05; Lot Numbers: Lot 56658012 exp 1/1/202430 kits
Z-0673-2023DeRoyal NEURO PACK, REF 89-10171.03; Lot Numbers: Lot 55790353 exp 4/1/2026; Lot 56387785 exp 5/1/2026162 kits
Z-0674-2023DeRoyal NEURO PACK, REF 89-10171.05; Lot Numbers: Lot 56927104 exp 5/1/202660 kits
Z-0675-2023DeRoyal NEURO PACK, REF 89-10171.06; Lot Numbers: Lot 57184744 exp 5/1/2026; Lot 57685899 exp 3/1/2024159 kits
Z-0676-2023DeRoyal CRANI PACK, REF 89-10202.03; Lot Numbers: Lot 56705261 exp 6/1/202516 kits
Z-0677-2023DeRoyal CRANI PACK, REF 89-10202.05; Lot Numbers: Lot 57389117 exp 9/1/20616 kits
Z-0678-2023DeRoyal LAMINECTOMY PACK, REF 89-10209.02; Lot Numbers: Lot 56388471 exp 6/1/202612 kits
Z-0679-2023DeRoyal LUMBAR FUSION PACK, REF 89-10211.05; Lot Numbers: Lot 57714741 exp 8/1/202451 kits
Z-0680-2023DeRoyal PACEMAKER ICD PACK, REF 89-10216.03; Lot Numbers: Lot 56705350 exp 6/1/202690 kits
Z-0681-2023DeRoyal PACEMAKER ICD PACK, REF 89-10216.06; Lot Numbers: Lot 57898501 exp 3/1/202775 kits
Z-0682-2023DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03; Lot Numbers: Lot 56465579 exp 7/1/202656 kits
Z-0683-2023DeRoyal CRANI PACK, REF 89-10242.02; Lot Numbers: Lot 56388307 exp 8/1/20236 kits
Z-0684-2023DeRoyal CRANI PACK, REF 89-10242.04; Lot Numbers: Lot 5688188 exp 8/1/20238 kits
Z-0685-2023DeRoyal HAND PACK, REF 89-10314.02; Lot Numbers: Lot 56615021 exp 6/1/202618 kits
Z-0686-2023DeRoyal HAND PACK, REF 89-10314.03; Lot Numbers: Lot 57685848 exp 8/1/202436 kits
Z-0687-2023DeRoyal PAIN TRAY, REF 89-10464.02; Lot Numbers: Lot 55971883 exp 7/1/2026; Lot 56477511 exp 7/1/2026; Lot 57002921 exp 9/1/20261100 kits
Z-0688-2023DeRoyal PAIN TRAY, REF 89-10464.03; Lot Numbers: Lot 57752107 exp 12/1/2026150 Kits
Z-0689-2023DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03; Lot Numbers: Lot 56618811 exp 6/1/2023; Lot 56779017 exp 1/1/2024; Lot 57148495 exp 2/1/202468 kits
Z-0690-2023DeRoyal CNRV SPINAL PACK, REF 89-10532.03; Lot Numbers: Lot 57188745 exp 3/1/2024; Lot 57393378 exp 5/1/2024; Lot 57663075 exp 05/01/202469 kits
Z-0691-2023DeRoyal CARDIAC LINEN PACK, REF 89-10543.02; Lot Numbers: Lot 56336988 exp 11/1/2023; Lot 57188770 exp 8/1/2024; Lot 57393440 exp 5/1/2024; Lot 57644325 exp 7/1/2024204 kits
Z-0692-2023DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01; Lot Numbers: Lot 56190288 exp 8/1/2023; Lot 56224943 exp 8/1/2023; Lot 56432718 exp 2/1/2023; Lot 56432726 exp 8/1/2023; Lot 56639065 exp 8/1/2023; Lot 56906961 exp 8/1/2023; Lot 57051271 exp 8/1/2023; Lot 57228161 exp 8/1/2023; Lot 57393491 exp 1/1/2024; Lot 57488967 exp 3/1/2024; Lot 57679350 exp 3/1/2024; Lot 57685371 exp 3/1/2024; Lot 57751551 exp 3/1/20241196 kits
Z-0693-2023DeRoyal LUMBAR DISC PACK, REF 89-10590.02; Lot Numbers: Lot 57022219 exp 3/1/20246 kits
Z-0694-2023DeRoyal LUMBAR DISC PACK, REF 89-10605.02; Lot Numbers: Lot 57241041 exp 2/1/2024; Lot 57590494 exp 5/1/202412 kits
Z-0695-2023DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01; Lot Numbers: Lot 55970901 exp 11/1/2023; Lot 57591032 exp 1/1/202419 kits
Z-0696-2023DeRoyal GU PACK, REF 89-10665.02; Lot Numbers: Lot 55971461 exp 5/1/202475 kits
Z-0697-2023DeRoyal GU PACK, REF 89-10665.03; Lot Numbers: Lot 57590304 exp 6/1/202357 kits
Z-0698-2023DeRoyal NEURO PACK, REF 89-10682.02; Lot Numbers: Lot 56225794 exp 12/1/2023; Lot 56619110 exp 9/1/2023; Lot 57227898 exp 4/11/2024; Lot 57927051 exp 5/1/2024270 kits
Z-0699-2023DeRoyal LAMI/CRANI PACK, REF 89-10787.01; Lot Numbers: Lot 56219159 exp 4/1/2026; Lot 56593562 exp 4/1/202636 kits
Z-0700-2023GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01; Lot Numbers: Lot 56618893 exp 6/1/2024; Lot 57002242 exp 6/1/2024; Lot 57187646 exp 6/1/20170 kits
Z-0701-2023DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02; Lot Numbers: Lot 56865450 exp 1/1/202432 kits
Z-0702-2023DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01; Lot Numbers: Lot 57187574 exp 4/1/2024180 kits
Z-0703-2023DeRoyal PACEMAKER ICD PACK, REF 89-10902.01; Lot Numbers: Lot 57805969 exp 11/1/202660 kits
Z-0704-2023DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02; Lot Numbers: Lot 57749071 exp 2/1/202410 kits
Z-0705-2023DeRoyal BIOPSY PACKPACK, REF 89-9756.05; Lot Numbers: Lot 56842493 exp 8/1/2026120 units
Z-0706-2023DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02; Lot Numbers: 56296761 exp 10/01/2023; 56717318 exp 11/01/2023; 57136671 exp 11/01/2023; 57225673 exp 11/01/2023; 57225817 exp 02-01-2024; 57455920 exp 02-01-2024; 57646161 exp 02-01-2024; 57889699 exp 02-01-2024; 58003853 exp 02-01-2024117 kits
Z-0707-2023DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02; Lot Numbers: 56169083 exp 12/01/2023; 56357092 exp 12/01/2023; 56481018 exp 12/01/2023; 56538205 exp 09/01/2023; 56873265 exp 09/01/2023; 56895966 exp 09/01/2023; 56942611 exp 03/01/2024; 57088584 exp 03/01/2024; 57088592 exp 03/01/2024; 57180516 exp 03/01/2024; 57270562 exp 03/01/2024; 57313163 exp 03/01/2024; 57313171 exp 03/01/2024; 57492608 exp 03/01/2024; 57646152 exp 03/01/2024; 57681329 exp 03/01/2024; 57717598 exp 03/01/2024; 57788708 exp 03/01/2024; 57889681 exp 03/01/2024; 57928563 exp 03/01/2024; 57960070 exp 03/01/2024; 58003845 exp 04/01/2024; 58032523 exp 04/01/2024336 kits
Z-0708-2023DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02; Lot Numbers: 56573668 exp 45170; 56670564 exp 45170; 56847198 exp 45170; 57564851 exp 45323; 57889672 exp 45323; 58032515 exp 45323;72 kits
Z-0709-2023GEO-MED CATARACT PACK, REF 89-5790.08; Lot Numbers: 55966890 exp 02/01/2023; 56020131 exp 03/01/2023; 56184435 exp 02/01/2023; 56618387 exp 06/01/2023; 57001493 exp 06/01/2023; 57227821 exp 09/01/2023; 57466709 exp 09/01/2023; 57589522 exp 09/01/2023; 57749750 exp 12/01/2023; 5786389 ezp 12/01/2023834 kits
Z-0710-2023DeRoyal CATARACT PACK, REF 89-8650.10; Lot Numbers: 55749537 exp 08/01/2023;440 kits
Z-0711-2023DeRoyal CATARACT PACK, REF 89-8859.08; Lot Numbers: 57755800 exp 12/01/2026;530 kits
Z-0712-2023DeRoyal CATARACT PACK, REF 89-9241.03; Lot Numbers: 55990451 exp 08/01/2024; 56615717 exp 08/01/2024368 kits
Z-0713-2023DeRoyal CATARACT PACK, REF 89-9241.04; Lot Numbers: 57198898 exp 12/01/2024; 57686605 exp 04/01/2025; 57754049 exp552 units
Z-0714-2023DeRoyal CATARACT PACK, REF 89-10040.01; Lot Numbers: 56125881 exp 05/01/2026; 56618926 exp 05/01/2026; 57485029 exp 11/01/2026108 kits
Z-0715-2023DeRoyal CATARACT PACK, REF 89-10086.05; Lot Numbers: 57003552 exp 09/01/2024; 57467226 exp 12/01/2024; 55748075 exp *; 56250244 exp *; 57899344 exp *; 57913353 exp *520 kits
Based on the official FDA remedy

What to do — step by step

  1. Stop Using It Now

    Immediately stop using the DeRoyal MYELOGRAM PACK with the listed lot numbers as they pose a fire risk.

Where it went and when

Where it was distributed

Distributed in 23 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Wisconsin.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Nov 3, 202212. FDA classified it Class II: Dec 15, 202223. Published in FDA’s Enforcement Report: Dec 21, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0647-2023 (November 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0647-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA