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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Centurion Sterile Weitlaner Retractors Recalled for Sterile Packaging Breach

Agency Publication Date: May 15, 2025
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Summary

Medline Industries, LP is recalling approximately 2,940 Centurion Sterile Weitlaner Retractors because the devices may puncture their own sterile packaging. If the packaging is breached, the retractors are no longer sterile, which can expose patients to contaminants during surgery. This recall affects reorder numbers 67315 and I68395 across multiple production lots. There have been no reported incidents or injuries related to this issue at this time.

Risk

A puncture in the sterile packaging compromises the safety of the surgical instrument. Using a non-sterile device during medical procedures can lead to serious surgical site infections or other healthcare-associated illnesses.

What You Should Do

  1. This recall affects Centurion Sterile Weitlaner Retractors (reorder numbers 67315 and I68395) sold in sterile packaging.
  2. Check the reorder number and lot number printed on the device packaging to determine if your inventory is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Medline Industries, LP or your distributor to arrange for a return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Centurion Sterile Weitlaner Retractor
Model / REF:
67315
Lot Numbers:
2020092801
2020100601
2021022601
2021032301
2021042301
2021060101
2021062101
2021090790
2022021190
2022032390
2022040690
2022061690
2022072690
2022091490
2023020990
2023100590
2023120790
2024012990
2024022290
2024040590
2024070290
2024080190
2024092790
2025011490
UDI:
10653160379867
00653160379860

UDI DI 10653160379867 (each) and 00653160379860 (case).

Product: Centurion Sterile Weitlaner Retractor 3 x 4 Prong
Variants: 3 x 4 Prong
Model / REF:
I68395
Lot Numbers:
2020061990
2020070990
2020110490
2020111090
2021082590
2021121490
2022062890
2022110190
2022121990
2023032290
2023032390
2023092590
2024050790
2024053090
2024062490
2024070190
UDI:
10653160287018
00653160287011

UDI DI 10653160287018 (each) and 00653160287011 (case).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96732
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply distributors; Medical device suppliers
Manufactured In: United States
Units Affected: 2 products (2100 units; 840 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.