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Unrated Medical device recall · FDA · Published April 17, 2023

DeRoyal Sterile Surgical Packs Recall: Light Handle Covers Recalled by Another Firm

DeRoyal Industries recalls sterile surgical procedure packs with light handle covers that were previously recalled by another company. Affected packs have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-1692-2023Medical deviceDeRoyal Industries ›
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Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703
✎ GovInfoNow plain-language explainer

DeRoyal Industries is recalling sterile surgical procedure packs that contain light handle covers previously recalled by another manufacturer. This recall is due to the risk of these covers being recalled by another firm, though the specific hazard isn't detailed in the notice. Read more at govinfonow.com/recall/58546-deroyal-sterile-surgical-packs-recall-light-handle-covers-recalled-by.

Source Summary by GovInfoNow · govinfonow.com/recall/58546-deroyal-sterile-surgical-packs-recall-light-handle-covers-recalled-by · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1692-2023

Cite this page

“DeRoyal Sterile Surgical Packs Recall: Light Handle Covers Recalled by Another Firm.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58546-deroyal-sterile-surgical-packs-recall-light-handle-covers-recalled-by. Based on FDA recall #Z-1692-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1692-2023%22&limit=1).

The FDA announced on April 17, 2023, that DeRoyal Industries Inc is recalling sterile custom surgical procedure packs because they contain light handle covers recalled by another firm. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: DeRoyal Industries
  • Product: Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339
  • Product: Sterile custom surgical procedure packs (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital; lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305
  • Quantity: 23 cases (52 packs)
  • Distribution: US Nationwide distribution in the state of VA

The hazard

The custom procedure packs contain light handle covers that have been recalled by another firm, according to the FDA.

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Other recent recalls of similar products include Medline ARTHROSCOPY PACK Recall (Feb. 25, 2026), Covidien Dermalon 4-0 Blue 75cm Sutures Recall (June 24, 2026), and Covidien V-Loc 180 Absorbable Wound Closure Device Recall (June 24, 2026).

How to tell if you have this one

Check for lot numbers 58700691 (expiring 11/1/2024) or 58700026 (expiring 12/1/2024) on the packs. The packs are labeled with specific GTIN and case numbers.

  • Brand
    DeRoyal Industries
  • Category
    Medical device
FDA recall event · 2 products

All 2 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 Nationwide distribution in the state of VA.
Recall numberProduct, codes & lotsQuantity
Z-1691-2023Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.; (1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, GTIN pack-00749756363549, case-50749756363544; (12) 89-10553.02 - lot 58544060, exp 11/1/2024, GTIN pack-00749756363624, case-50749756363629; (13) 89-10554.02 - lot 58544166, exp 12/1/2024, GTIN pack-00749756363440, case-50749756363445; (14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, GTIN pack-00749756363648, case-50749756363643; (15) 89-10556.02 - lot 58589567, exp 12/1/2024, GTIN pack-00749756364287, case-50749756364282; (16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, GTIN pack-00749756364430, case-50749756364435; (17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, GTIN pack-00749756363778, case-50749756363773; (18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, GTIN pack-00749756363723, case-50749756363728; (19) 89-10562.02 - lot 58621820, exp 10/1/2024, GTIN pack-00749756364140, case-50749756364145; (20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, GTIN pack-00749756363761, case-50749756363766; (21) 89-10569.02 - lot 58544182 exp 12/1/2024, GTIN pack-00749756363457, case-50749756363452; (22) 89-10570.02 - lot 58700739, exp 1/1/2024, and 58775036, exp 3/14/2024, GTIN pack-00749756363587, case-50749756363582; (23) 89-10574.02 - lot 58700641, exp 7/1/2024, GTIN pack-00749756364041, case-50749756364046; (24) 89-10575.02 - lot 58565848, exp 12/1/2023, GTIN pack-00749756366144, case-50749756366149; (25) 89-10576.03 - lot 58700704, exp 12/1/2024, GTIN pack-00749756364126, case-50749756364121; (26) 89-10580.03 - lot 58543454, exp 8/1/2024, GTIN pack-00749756366328, case-50749756366323.1,391 cases (2,972 packs)
Z-1692-2023Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.; (1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.23 cases (52 packs)
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for lot numbers 58700691 (expiring 11/1/2024) or 58700026 (expiring 12/1/2024) on the packs.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Apr 17, 202312. FDA classified it Class II: Jun 7, 202323. Published in FDA’s Enforcement Report: Jun 14, 202332023
  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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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-1692-2023 (April 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1692-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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