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Lower risk Medical device recall · FDA · Published February 22, 2022

Busse Pellet Insertion Tray Recall: Drug Safety Concerns

Busse Hospital Disposables recalls 3.2MM Pellet Insertion Trays (Catalog B9743) due to drug safety concerns from manufacturing validation uncertainty. Affected units include specific lot numbers.

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

🇺🇸 FDA recall #Z-1203-2022Medical deviceBusse Hospital Disposables ›
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Contact the company

Recalling firmBusse Hospital Disposables, Inc.75 Arkay Dr · Hauppauge, NY 11788-3707
✎ GovInfoNow plain-language explainer

Busse Hospital Disposables is recalling 3.2 million pellet insertion trays (Catalog B9743) because the drug products inside may not be manufactured safely due to uncertain test validation. This could affect patients using these trays for medical procedures. Read more at govinfonow.com/recall/61059-busse-pellet-insertion-tray-recall-drug-safety-concerns.

Source Summary by GovInfoNow · govinfonow.com/recall/61059-busse-pellet-insertion-tray-recall-drug-safety-concerns · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1203-2022

Cite this page

“Busse Pellet Insertion Tray Recall: Drug Safety Concerns.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61059-busse-pellet-insertion-tray-recall-drug-safety-concerns. Based on FDA recall #Z-1203-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2022%22&limit=1).

The Food and Drug Administration announced on Feb. 22, 2022, that Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays (Catalog Number B9743) due to drug product uncertainty. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Busse Hospital Disposables
  • Product: 3.2MM Pellet Insertion Tray
  • Catalog Number: B9743
  • Lot Numbers: 2031128, 2130202, 2131304
  • UDI: 00849233011649

The hazard

The recall involves Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International. The hazard stems from uncertainty regarding the adequacy of validation of the test methods used to manufacture these drug products.

Context

GovInfoNow's records show Busse Hospital Disposables has two other recalls on record since Oct. 21, 2022. On Nov. 30, 2023, the firm recalled Tracheostomy Care Trays due to infection risk from Nurse Assist Sterile 0.9% Normal Saline lots. On Oct. 21, 2022, Busse Joint Injection Trays were recalled because an adhesive liner could damage the product. Other recent recalls of similar products include Medline Convenience Kits Block Tray Recall (May 21, 2026), Becton Dickinson Spinal Tray Recall (April 27, 2026), and B. Braun Medical CESK Northside Anesthesia Tray Recall (Jan. 29, 2026).

How to tell if you have this one

Check for Catalog Number B9743 on the tray. Affected units include Lot Numbers 2031128, 2130202, and 2131304. The tray has a unique identifier (UDI) starting with 00849233011649.

  • Brand
    Busse Hospital Disposables
  • Category
    Medical device
FDA recall event · 58 products

All 58 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
    Terminated
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantity
Z-1147-2022I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822; Lot Numbers: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 008492330100172475
Z-1148-2022Procedure Tray Catalog 1065; Lot Numbers: 2030699 2130342 UDI: 0084923300335446 units
Z-1149-2022Cervical Tray Catalog 1089; Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 0084923300041480
Z-1150-2022Lumbar Tray Catalog 1091; Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000247330 units
Z-1151-2022Single Shot Epidural Tray Catalog 1165; Lot Numbers: 2130290 2131184 UDI: 0084923300648520 units
Z-1152-2022Single Shot Epidural Tray Catalog 1292; Lot Numbers: 2130282 2130576 2131060 UDI: 0084923300364460 units
Z-1153-2022Epidural Tray Catalog 1307; Lot Numbers: 2131254 UDI: 0084923300366864 units
Z-1154-2022Universal Tray Catalog 1567; Lot Numbers: 2130419 2130880 2131187 UDI: 0084923300565596 units
Z-1155-2022Epidural Tray Catalog 1577; Lot Numbers: 2130426 2130801 2131032 2131138 2131290 UDI: 0084923300654680 units
Z-1156-2022Port Tray Catalog 7607; Lot Numbers: 2010357 2110129 2110181 2110225 2110252 UDI: 00849233014176576 units
Z-1157-2022I.V. Start Kit Catalog 8172; Lot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 008492330158834218 units
Z-1158-2022Nerve Block Tray Catalog Number: 8415; Lot Numbers: 2030832 2031190 2130252 2130629 2130742 2131125 2131223 UDI: 00849233016811420 units
Z-1159-2022Single Shot Epidural Tray Catalog Number: 8417; Lot Numbers: 2130077 2130313 2130630 2130945 2131091 UDI: 00849233016804400 units
Z-1160-2022Nerve Block Tray Catalog Number: 9342; Lot Numbers: 2031019S 2130222S UDI: 0084923300907364 units
Z-1161-2022Universal Nerve Block Tray Catalog Number: 9779; Lot Numbers: 2031030 2130009 2130328 2130645 UDI: 00849233012134400 units
Z-1162-2022Universal Nerve Block Tray Catalog Number: 9818; Lot Numbers: 2030783 2031093 2130287 2130412 2130681 2131043 UDI:0084923301204260 units
Z-1163-2022MBB Tray Catalog Number: 9882; Lot Numbers: Lot 2130220 2130445 2131063 UDI: 0084923300017960 units
Z-1164-2022Pain Tray Catalog Number: 9883; Lot Numbers: 2031092 2130020 2130288 2130670 2130020 2130905 2131181 2131317 UDI: 00849233012158421 units
Z-1165-2022Stereo Breast Biopsy Tray Catalog Number: 2383R1; Lot Numbers: 2130565 UDI: 0084923300434423 units
Z-1166-2022CVC Dressing Change Kit Catalog Number: 2491R1; Lot Numbers: 2020472 2020519 2020651 2020759 UDI: 00849233004481200 units
Z-1167-2022Nerve Block Tray Catalog Number: 3764R2; Lot Numbers: 2030839 2030974 2130490 2130900 2131293 UDI: 00849233015197250 units
Z-1168-2022Cervical Tray Catalog Number: 3765R2; Lot Numbers: 2031213S 2130221S UDI: 0084923301520340 units
Z-1169-2022Single Shot Epidural Tray Catalog Number: 6183R1; Lot Numbers: 2030967 2031172 2031272 2130029 2130151 2130298 2130357 2130459 2130527 2130593 2130716 2130863 2130975 2131088 2131120 2131224 2131248 UDI: 00849233007857425 units
Z-1170-2022Sterile Epidural Tray Catalog Number: 6259R2; Lot Numbers: 2130839 2131167 2131230 2131210 UDI: 0084923300027850 units
Z-1171-2022Nerve Block Tray Catalog Number: 6796R3; Lot Numbers: 2031026 2031218 2130212 2130896 UDI: 00849233015944200 units
Z-1172-2022Single Shot Epidural Tray Catalog Number: 6797R2; Lot Numbers: 2030835 2031025 2031217 2130006 UDI: 0084923301465740 units
Z-1173-2022Pump Refill Kit Catalog Number: 7347R1; Lot Numbers: 2030921 2130507 UDI: 0084923300936340 units
Z-1174-2022Single Shot Epidural Tray - 18G Catalog Number: 8139R2; Lot Numbers: 2031049 2131128 UDI: 0084923301589020 units
Z-1175-2022Joint Injection Tray Catalog Number: 8561R1; Lot Numbers: Lot 2031105 2130068 2130167 2130508 2130862 2131115 UDI: 00849233016712480 units
Z-1176-2022Core Biopsy Tray Catalog Number: 8673R4; Lot Numbers: 2031043 2130119 2130382 2130830 2130997 UDI: 00849233017092285 units
Z-1177-2022Bone Marrow Biopsy Tray Catalog Number: 8917R1; Lot Numbers: 2020741 2120119 2120119 2120342 2120630 UDI: 0084923300201280 units
Z-1178-2022Procedural Accessory Kit Catalog Number: 9665R2; Lot Numbers: 2031038 UDI: 00860000210461250 units
Z-1179-20223.2MM Pellet Insertion Tray Catalog Number: B1144; Lot Numbers: 2010270 2110081 2110173 2110220 UDI: 00849233003835120 units
Z-1180-2022"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351; Lot Numbers: 2110082 2110174 2110254 2110221 UDI: 00849233004733120 units
Z-1181-2022SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352; Lot Numbers: 2010298 UDI: 0084923300471930 units
Z-1182-2022SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1; Lot Numbers: 2110100 2110083 2110226 2110262 UDI: 00849233004719120 units
Z-1183-2022SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354; Lot Numbers: 2010304 UDI: 0084923300464130 units
Z-1184-2022SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1; Lot Numbers: 2110102 2110090 2110268 UDI: 0084923300464190 units
Z-1185-20224.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360; Lot Numbers: 2010336 UDI: 0084923300462730 units
Z-1186-20224.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362; Lot Numbers: 2110098 UDI: 0084923300461030 units
Z-1187-2022SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363; Lot Numbers: 2010337 UDI:0084923300651530 units
Z-1188-2022SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1; Lot Numbers: 2110127 2110269 UDI: 0084923300651560 units
Z-1189-2022SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1; Lot Numbers: 2110128 2110279 UDI: 0084923300441260 units
Z-1190-2022SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547; Lot Numbers: 2110054 2110116 UDI: 0084923300536560 units
Z-1191-2022SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555; Lot Numbers: Lot 2110053 2110115 UDI: 0084923300540260 units
Z-1192-2022SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559; Lot Numbers: 2110052 UDI: 0084923300541930 units
Z-1193-2022SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560; Lot Numbers: 2110059 UDI: 0084923300542630 units
Z-1194-2022Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568; Lot Numbers: 2130338 2130562 UDI: 00849233005525100 units
Z-1195-2022Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570; Lot Numbers: 2130324 UDI: 0084923300555648 units
Z-1196-2022Pellet Insertion Tray Catalog Number: B1654; Lot Numbers: 2130616 UDI: 0084923300602750 units
Z-1197-20223.2MM Pellet Insertion Tray Catalog Number: B7345R1; Lot Numbers: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996250 units
Z-1198-2022SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1; Lot Numbers: 2030982 2031072 2130198 2130352 2130706 2130876 UDI: 00849233002227300 units
Z-1199-20224.5 MM Pellet Insertion Tray Catalog Number: B8121R1; Lot Numbers: 2031076 2130823 UDI:0084923301730699 units
Z-1200-2022SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1; Lot Numbers: 2130197 UDI: 0084923300185550 units
Z-1201-2022Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1; Lot Numbers: Lot 2030875 2030980 2031048 2031048 2031096 2031048 2031096 2130563 2130722 UDI: 008492330111821040 units
Z-1202-2022Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1; Lot Numbers: 2031047 2031162 2130578 2130723 UDI: 00849233011151360 units
Z-1203-20223.2MM Pellet Insertion Tray Catalog Number: B9743; Lot Numbers: 2031128 2130202 2131304 UDI: 00849233011649150 units
Z-1204-2022SS 4.5MM Pellet Insertion Tray Catalog Number: B9807; Lot Numbers: 2031228 UDI: 0084923300355250 units
Based on the official FDA remedy

What to do — step by step

  1. Check Tray Details

    Look for Catalog Number B9743 and Lot Numbers 2031128, 2130202, or 2131304 on the tray.

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: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Feb 22, 202212. FDA classified it Class II: May 28, 202223. Published in FDA’s Enforcement Report: Jun 8, 202234. FDA terminated the recall: Apr 17, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-1203-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1203-2022 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