Skip to content
Lower risk Medical device recall · FDA · Published June 27, 2017

Busse Safety Deluxe Bone Marrow Tray Recall: Loose Polypropylene Foreign Matter

Busse Hospital Disposables recalls Safety Deluxe Bone Marrow Biopsy/Aspiration Trays (Catalog #986) due to potential loose polypropylene foreign matter. Affected units include specific lot numbers with expiration dates.

🇺🇸 FDA recall #Z-0546-2018Medical deviceBusse Hospital Disposables ›
Take action

Contact the company

Recalling firmRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables75 Arkay Dr · Hauppauge, NY 11788-3707
✎ GovInfoNow plain-language explainer

What happened, in plain English

Busse Hospital Disposables is recalling Safety Deluxe Bone Marrow Biopsy/Aspiration Trays (Catalog #986) because they may contain loose polypropylene foreign matter. This could pose a risk during surgical procedures if the foreign material causes injury. Read more at govinfonow.com/recall/73547-busse-safety-deluxe-bone-marrow-tray-recall-loose-polypropylene-foreign.

Source Summary by GovInfoNow · govinfonow.com/recall/73547-busse-safety-deluxe-bone-marrow-tray-recall-loose-polypropylene-foreign · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0546-2018

Cite this page

“Busse Safety Deluxe Bone Marrow Tray Recall: Loose Polypropylene Foreign Matter.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73547-busse-safety-deluxe-bone-marrow-tray-recall-loose-polypropylene-foreign. Based on FDA recall #Z-0546-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2018%22&limit=1).

Why it’s dangerous

The trays may contain loose polypropylene foreign matter that could become a hazard during surgical procedures. If the foreign material is dislodged, it might cause injury to the patient or the surgical team.

Who’s affected

Surgical teams using the Safety Deluxe Bone Marrow Biopsy/Aspiration Trays (Catalog #986) are affected. The risk is highest for medical professionals performing bone marrow procedures.

How to tell if you have this one

Check for the Safety Deluxe Bone Marrow Biopsy/Aspiration Tray with Catalog #986. Affected units have specific lot numbers: 1620888 (expires 12/30/2017) or 1620367 (expires 09/01/2017).

  • Brand
    Busse Hospital Disposables
  • Category
    Medical device
FDA recall event · 7 products

All 7 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
    US Nationwide Distribution
Recall numberProduct, codes & lotsQuantity
Z-0540-2018Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure; Lot Number/Expiration Date: 1) 1610300/Expiration Date 03/01/2019; 2) 1610503/Expiration Date 05/30/2019; 3) 1710059/Expiration Date: 09/30/2019; 4) 1610383/Expiration Date: 02/28/2019; 5) 1610463/Expiration Date: 05/30/2019; 6) 1610215/Expiration Date: 02/01/2019; 7) 1610114/Expiration Date: 11/01/2018; 8) 1610044/Expiration Date: 06/01/2018;470 cases
Z-0541-2018Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610277/Expiration Date: 03/01/201928 cases
Z-0542-2018Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1610197/Expiration Date: 12/01/2018; 2) 1610204/Expiration Date: 02/01/2019; 3) 1610075/Expiration Date: 06/01/2018; 4) 1610431/Expiration Date: 05/30/2019; 5) 1610246/Expiration Date: 02/01/2019; 6) 1610204/Expiration Date: 02/01/201982 cases
Z-0543-2018Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1720047/Expiration Date: 02/20/20185 cases
Z-0544-2018Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1730650/Expiration Date: 10/30/2021; 2) 1630921/Expiration Date: 11/02/2020; 3) 1631124/Expiration Date: 10/30/2020; 4) 1631386/Expiration Date: 05/30/2021; 5) 1631679/Expiration Date: 05/30/202175 cases
Z-0545-2018Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1710206/Expiration Date: 05/30/2022; 2) 1710040/Expiration Date: 01/30/2022; 3) 1610536/Expiration Date: 12/30/2021; 4) 1610423/No Expiration Date; 5) 1610351/No Expiration Date; 6) 1610219/No Expiration Date; 7) 1610090/No Expiration Date1037 in total
Z-0546-2018Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure; Lot Numbers/Expiration Dates: 1) 1620888/Expiration Date: 12/30/2017 2) 1620367/Expiration Date: 09/01/201715 cases
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the tray's catalog number (986) and lot numbers (1620888 or 1620367) to confirm if it is affected.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Jun 27, 201712. FDA classified it Class II: Feb 6, 201823. Published in FDA’s Enforcement Report: Feb 14, 201834. FDA terminated the recall: Jul 27, 2020420172020
  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.

Similar recalls

Latest medical device recalls

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-0546-2018 (June 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0546-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 21, 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