DeRoyal Organ Recovery Packs: Risk of Sterile Barrier Breach in Surgical Sutures
DeRoyal recalls specific organ recovery packs with Medtronic non-absorbable sutures due to potential packaging gaps causing sterile barrier breaches. Affected lots have expiration dates through May 2023.
Use caution until it’s fixed
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
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What happened, in plain English
DeRoyal is recalling certain organ recovery packs that contain Medtronic non-absorbable sutures. The recall is because a manufacturing error might create a gap in the packaging, risking a sterile barrier breach during surgery. Read more at govinfonow.com/recall/59170-deroyal-organ-recovery-packs-risk-of-sterile-barrier-breach-in.
Source Summary by GovInfoNow · govinfonow.com/recall/59170-deroyal-organ-recovery-packs-risk-of-sterile-barrier-breach-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0927-2023
Cite this page
“DeRoyal Organ Recovery Packs: Risk of Sterile Barrier Breach in Surgical Sutures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59170-deroyal-organ-recovery-packs-risk-of-sterile-barrier-breach-in. Based on FDA recall #Z-0927-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0927-2023%22&limit=1).
Why it’s dangerous
The packaging error could create a gap or wrinkle in the breather seal of the sterile barrier. This might allow contamination to enter the surgical site, increasing the risk of infection.
Who’s affected
Surgical teams and hospitals using the recalled organ recovery packs. Patients undergoing surgery with these packs are at risk of infection.
How to tell if you have this one
Check for the product name 'DeRoyal ORGAN RECOVERY PACK PGYBK' with lot numbers 57391129, 57755421, 57900931 (expiring May 1, 2023) or 57913767 (expiring May 1, 2023).
- Brand
DeRoyal- Product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10- Category
Medical device
What to do — step by step
Check Product Details
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your pack is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of IL, MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Missouri.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- 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-0927-2023 (December 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0927-2023 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.