Integra Scalp Clips Recall: Wrinkled Packaging May Compromise Sterile Barrier
Integra LifeSciences recalls disposable scalp clips with wrinkled packaging that could compromise sterile barrier. Affected units include specific part numbers and lot numbers. Consumers should check packaging for wrinkles and contact Integra for details.
Lower-risk recall
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Contact the company
What happened, in plain English
Integra LifeSciences is recalling disposable scalp clips that may have wrinkled packaging. This could compromise the sterile barrier, risking infection during medical procedures. Affected units have specific part numbers and lot numbers. Read more at govinfonow.com/recall/62442-integra-scalp-clips-recall-wrinkled-packaging-may-compromise-sterile-barrier.
Source Summary by GovInfoNow · govinfonow.com/recall/62442-integra-scalp-clips-recall-wrinkled-packaging-may-compromise-sterile-barrier · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2224-2021
Cite this page
“Integra Scalp Clips Recall: Wrinkled Packaging May Compromise Sterile Barrier.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62442-integra-scalp-clips-recall-wrinkled-packaging-may-compromise-sterile-barrier. Based on FDA recall #Z-2224-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2021%22&limit=1).
Why it’s dangerous
Wrinkles in the packaging may compromise the sterile barrier, potentially allowing contaminants to enter the wound site. This could increase infection risk during medical procedures.
Who’s affected
Patients using these scalp clips for wound hemostasis are most at risk. The recall affects specific part numbers and lot numbers sold through medical suppliers.
How to tell if you have this one
Check the packaging for wrinkles on the Tyvek side. Affected units have part number 201037 and lot numbers W2102045, W2102046, W2102048, and W2102049.
- Brand
Integra LifeSciences- Product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part- Category
Medical device
What to do — step by step
Check Packaging for Wrinkles
Inspect the packaging for wrinkles on the Tyvek side, which may compromise the sterile barrier.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide Distribution - Foreign Distribution: Hong Kong” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2224-2021 (June 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2224-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.