Lower risk Medical device recall · FDA · Published February 4, 2025

American Contract Systems CRANI PACK Medical Kit: Sterility Risk

American Contract Systems recalls CRANI PACK medical kits with model WECR41D due to potential failure in sterilization, risking infection during surgery. Affected kits have specific lot codes and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1406-2025Medical device American Contract Systems ›

Lower-risk recall

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

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Contact the company

Recalling firmAmerican Contract Systems Inc85 Shaffer Park Dr · Tiffin, OH 44883-9290

✎ GovInfoNow plain-language explainer

American Contract Systems is recalling medical procedure kits called CRANI PACK with model number WECR41D because they may not meet sterility standards. This could lead to infections during medical procedures if used improperly. Read more at govinfonow.com/recall/52977-american-contract-systems-crani-pack-medical-kit-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52977-american-contract-systems-crani-pack-medical-kit-sterility-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1406-2025

Cite this page

“American Contract Systems CRANI PACK Medical Kit: Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52977-american-contract-systems-crani-pack-medical-kit-sterility-risk. Based on FDA recall #Z-1406-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1406-2025%22&limit=1).

The FDA announced on Feb. 4, 2025, that American Contract Systems Inc is recalling the CRANI PACK medical procedure kit due to sterility concerns. The agency issued recall number Z-1406-2025 for the Class II device.

How to tell if you have it

Brand: American Contract Systems
Product: CRANI PACK, Model/Catalog Number WECR41D
Lot Codes: 71-052536 (Exp: 10/30/2025), 71-051491 (Exp: 07/16/2025), 71-051609 (Exp: 07/30/2025), 71-051767 (Exp: 08/14/2025), 71-053065 (Exp: 12/10/2025)
Distribution: Michigan
Units affected: 91

The hazard

The FDA said the recall is necessary because American Contract Systems Inc could not confirm that the CODMAN component achieved the required Sterility Assurance Level. Consequently, the component is not suitable for sterilization according to the company's procedures.

Context

GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since Nov. 21, 2018. Other recent recalls of similar products include Medical Convenience Kits with Contaminated Wipes Risk Infection (Aug. 10, 2026), American Contract Systems Convenience Kit Recall: Catheters May Not Meet Performance Specs (June 29, 2026), and American Contract Systems Medical Kits Recall: Potential Endotoxin Variability (May 19, 2026). Other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (Jan. 7, 2026).

How to tell if you have this one

Check for model number WECR41D on the CRANI PACK kit. Look for specific lot codes: 71-052536, 71-051491, 71-051609, 71-051767, or 71-053065, with expiration dates up to October 30, 2025.

Brand
American Contract Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for model number WECR41D and specific lot codes listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in Michigan.

FDA distribution: “US: MI” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan.

Recall timeline

FDA published this recall 50 days after the firm started it.

Feb 4, 2025Firm started the recall
Mar 20, 2025FDA classified it Class II
Mar 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More American Contract Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/52977-american-contract-systems-crani-pack-medical-kit-sterility-risk">American Contract Systems CRANI PACK Medical Kit: Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1406-2025 (February 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1406-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.