Medical Procedure Packs with Compromised Package Seals Recalled
DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical procedure packs where outer package seals could be compromised, affecting sterility. Although no illnesses or injuries have been reported, compromised sterility on surgical devices used in invasive procedures represents a risk-of-harm product, as non-sterile surgical packs could lead to serious infections or complications.
Plain-English summary
DeRoyal Industries Inc. is recalling 328 custom medical procedure packs distributed nationwide. The recalled products include Standard OB Pack, Angio Pack, Basin, Cysto Pack, Total Hip Pack, and Emergency C-Section Pack.
The outer package seals on these procedure packs could be open or compromised, which affects the sterility assurance of the packs. Medical procedure packs must maintain their sterile barrier to prevent contamination during surgical use.
These packs are used in hospitals and surgical centers for obstetric, cardiovascular, urological, and orthopedic surgeries. Any facility using these recalled products should discontinue use immediately and contact the manufacturer for instructions.
Customers who have received these affected lots should contact DeRoyal Industries Inc. for guidance on return or replacement of the recalled products.
The recalled product
- Product
- Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- seal-failure
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF 89-10640
- GTIN 50749756367740 (cs)
- 00749756367745 (unit)
- Lot Numbers: 58737945
- b) REF 89-10901
- GTIN 50749756380244 (cs)
- 00749756380249 (unit)
- Lot Numbers: 58820749
- c) REF 89-1924
- GTIN 50749756216864 (cs)
- 00749756216869 (unit)
- Lot Numbers: 58746227
- d) REF 89-7133
- GTIN 50749756736744 (cs)
- 00749756736749 (unit)
- Lot Numbers: 58789323
- e) REF 89-9134
- GTIN 50749756911332 (cs)
- 00749756911337 (unit)
- Lot Numbers: 58701336
Distribution
Distributed nationwide across the United States.
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