Suture Removal and Staple Remover Kits Recalled for Weak Seal
Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.
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: This is an FDA Class II recall of sterile surgical instruments with a manufacturing defect that could compromise sterility. No reported illnesses or injuries have been documented, and the hazard is a potential risk without evidence of actual patient harm.
Plain-English summary
Medline Industries, LP is recalling Centurion and Medline brand manual surgical kits, including suture removal trays, suture removal sets, and skin staple removers. Approximately 23,290 units were affected across multiple product codes and documented lot numbers.
The recalled kits may have weak seals that could result in a breach of product sterility if the seal fails. The weak seal defect may not be detectable by all users, meaning sterile instruments could be compromised without visible evidence of the defect.
The products were distributed worldwide, including throughout the United States, Panama, and Canada. Details on specific product codes, lot numbers, and UDI codes are available from the FDA and Medline Industries.
The recalled product
- Product
- Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 23,290
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 (19)
- a) TRI55405
- UDI/DI 20193489112709 (case) 10193489112702 (each)
- Lot Numbers: 2023022390 b) 60265
- UDI/DI 50653160090982 (case) 00653160090987 (each)
- Lot Numbers: 2023041190 MEDLINE: a) 60280
- UDI/DI 20193489111948 I(case) 10193489111941 (each)
- Lot Numbers: 2023031790
- 2023070590
- 2023112790
- b) 86125
- UDI/DI 20193489111832 (case) 10193489111835 (each)
- Lot Numbers: 2023032090
- 2023120490
- c) SR60555
- UDI/DI 20193489111955 (case) 10193489111958 (each)
- Lot Numbers: 2023111590
- d) TRI44105
- UDI/DI 20193489112730 (case) 10193489112733 (each)
- Lot Numbers: 2023072490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 29 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 29 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 · weak seal
See all →- HighMedline Convenience Kits Recalled for Potential Weak Seals
FDA (Devices) · 2025-04-23
- HighMedline sterile convenience kits recalled for potentially weak packaging seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- HighMedline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
Similar recalls
- HighMedline Centurion Medical Procedure Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- SevereMedline circumcision surgical kits recalled for sterility concerns
FDA (Devices) · 2024-03-06
- SevereMedline recalls Centurion Laceration Trays for potential sterility defect
FDA (Devices) · 2024-03-06
- SevereMedline Medical Kits and Trays Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- SevereMedline Surgical Kits and Trays Recalled Due to Potential Sterility Defect
FDA (Devices) · 2024-03-06
- ModerateMedline Plastics Suture Tray recalled due to leaking sterile liquid bottles
FDA (Devices) · 2025-05-07