Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DeRoyal ORGAN RECOVERY PACK PGYBK Recalled by DeRoyal Industries Inc Due to DeRoyal is recalling certain lots of surgical procedure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.
Affected Products
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Quantity: 157 packs
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DeRoyal Industries Inc
DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report