Centurion Sterile Weitlaner Retractor recalled for packaging puncture risk
Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as Class II. The source does not report any illnesses, injuries, or confirmed adverse events—only a potential for packaging puncture. The defect is precautionary in nature with no reported patient harm.
Plain-English summary
Medline Industries, LP is recalling the Centurion Sterile Weitlaner Retractor (Reorder 67315) nationwide. The recall affects 2,100 units distributed across the United States.
The retractors have the potential to puncture through the sterile packaging. This defect could compromise the sterility assurance of the surgical instrument, which is critical for safe surgical use.
Patients and healthcare providers who have received affected units should contact Medline Industries or their healthcare provider. The recalled lot numbers are: 2020092801, 2020100601, 2021022601, 2021032301, 2021042301, 2021060101, 2021062101, 2021090790, 2022021190, 2022032390, 2022040690, 2022061690, 2022072690, 2022091490, 2023020990, 2023100590, 2023120790, 2024012990, 2024022290, 2024040590, 2024070290, 2024080190, 2024092790, and 2025011490.
The recalled product
- Product
- Centurion Sterile Weitlaner Retractor, Reorder: 67315
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,100
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)
- UDI/DI 10653160379867 (each) 00653160379860 (case)
- Lot Numbers: 2020092801
- 2020100601
- 2021022601
- 2021032301
- 2021042301
- 2021060101
- 2021062101
- 2021090790
- 2022021190
- 2022032390
- 2022040690
- 2022061690
- 2022072690
- 2022091490
- 2023020990
- 2023100590
- 2023120790
- 2024012990
- 2024022290
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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