Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach
Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.
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 recall of a surgical medical device with potential sterility breach risk. No illnesses or injuries are reported in the source material, and the hazard is theoretical (depends on seal failure), placing this at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Centurion surgical retractor kits due to a weak seal that may result in a breach of sterility. The recalled products include the STERILE 6-1/2" SENN RETRACTOR (ST7185, Product Code 66795), the STERILE RAGNELL RETRACTOR (RR602, Product Code 67525), and the ST. SENN RETRACTOR 3 PRG BLUNT (ST7085, Product Code 37535).
A total of 760 units have been distributed. The weak seal may not be detectable by all users, and if the seal fails, the sterile contents could become contaminated. These are surgical instruments used in medical and surgical procedures where sterility is critical.
The affected products were distributed nationwide in the United States as well as to Panama and Canada. Specific lot numbers are associated with each product: Lots 2023030190, 2023052390, and 2023092590 for the SENN RETRACTOR; Lot 2023032490 for the RAGNELL RETRACTOR; and Lot 2023061490 for the ST. SENN RETRACTOR 3 PRG BLUNT.
Users who have these retractor kits should verify their product code and lot number against the recall notice. Contact Medline Industries for instructions on replacement or return of the affected products.
The recalled product
- Product
- Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 760
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 (11)
- a) 66795
- UDI/DI 50653160061180 (case) 00653160061185 (each)
- Lot Numbers: 2023030190
- 2023052390
- 2023092590
- b) 67525
- UDI/DI 10653160158639 (case) 00653160158632 (ease)
- Lot Numbers: 2023032490
- c) 37535
- UDI/DI 10653160169048 (case) 00653160169041 (each)
- Lot Numbers: 2023061490
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.
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