Centurion OB Tray medical kit recalled due to potential non-sterility
Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall. The hazard is potential non-sterility if seals are compromised, which poses a significant risk of harm in obstetric procedures. No illnesses or injuries have been reported, which limits the score to High per the rubric rule for theoretical hazards without reported illness.
Plain-English summary
Medline Industries is recalling Centurion OB TRAY (REF MNS13965A) medical procedure convenience kits that were packaged in specific breather pouches. The recall affects kits from breather pouch lot 323080002.
If the vendor seal on the breather pouch is opened or becomes unsealed, the kit contents may no longer maintain sterility. This creates the potential for non-sterile medical products to be used in procedures.
The affected kits were distributed worldwide, including throughout the United States, Canada, and Panama.
Healthcare facilities that received kits from this lot should inspect the breather pouch seals for any signs of opening or damage before use. Kits with unsealed or compromised seals should not be used. Any adverse events should be reported to Medline Industries or the FDA.
The recalled product
- Product
- Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 30
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 (3)
- UDI/DI 40653160995877 (each)
- 10653160995876 (case)
- Lot Numbers: 24ABD184
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 33 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · non sterile
See all →- SevereBeekeeper's Naturals saline nasal spray recalled for microbial contamination
FDA (Drugs) · 2026-06-17
- HighMedline Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline IV Start and Securement Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
FDA (Devices) · 2026-05-06
- HighMedline medical convenience kits recalled for non-sterile alcohol prep pads
FDA (Devices) · 2026-05-06
Similar recalls
- ModerateMedline Convenience Kits Recalled for Potentially Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled for Potential Open Breather Pouch Seals
FDA (Devices) · 2025-04-23
- ModerateSterile convenience kits recalled for potentially weak breather pouch seals
FDA (Devices) · 2025-04-23
- SevereMedline recalls Centurion Laceration Trays for potential sterility defect
FDA (Devices) · 2024-03-06
- HighMedline LINQ Surgical Trays Recalled for Compromised Pouch Seals
FDA (Devices) · 2022-11-09