Lower risk Medical device recall · FDA · Published May 3, 2018

Medtronic Clip Gun Magazines: Packaging Seal Risk

Medtronic recalls Clip Gun Magazines with potentially undetected packaging seal breaches that could compromise sterility during surgery. Affected units have specific lot numbers and are sold in sealed pouches.

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

🇺🇸 FDA recall #Z-3212-2018Medical device Medtronic ›

Lower-risk recall

The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.

Take action

Contact the company

Recalling firmMedtronic Neurosurgery125 Cremona Dr · Goleta, CA 93117-3083

✎ GovInfoNow plain-language explainer

Medtronic is recalling Clip Gun Magazines that may have packaging seals that don't show damage to the user's naked eye. This could mean the medical device isn't sterile when used, which is dangerous during surgery. Read more at govinfonow.com/recall/71212-medtronic-clip-gun-magazines-packaging-seal-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71212-medtronic-clip-gun-magazines-packaging-seal-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-3212-2018

Cite this page

“Medtronic Clip Gun Magazines: Packaging Seal Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71212-medtronic-clip-gun-magazines-packaging-seal-risk. Based on FDA recall #Z-3212-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3212-2018%22&limit=1).

The FDA announced on May 3, 2018, that Medtronic Neurosurgery is recalling Medtronic Clip Gun Magazines because the packaging sterile barrier does not comply with applicable standards. The agency said the seal breach may go undetected by the user's naked eye.

How to tell if you have it

Brand: Medtronic
Product: Medtronic Clip Gun Magazine
REF: CM8902
UDI-Device Identifier (GTIN/UPN): 20643169647200
Lot Numbers: 54984, 57188, 59558, 66312, and 67988

The hazard

The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use state do not use if package has been previously opened or damaged, it is possible that the seal breach may go undetected by the user's naked eye.

Context

GovInfoNow's records show Medtronic Neurosurgery has 9 other recalls on record since Dec. 20, 2017. Other recent recalls of similar products include Medtronic Neurosurgery Ventriculostomy Kit Recall: Endotoxin Risk (June 17, 2026), Medtronic Exacta External Drainage System: Cracks or Leaks in Stopcocks (Nov. 1, 2024), and Medtronic Duet Drainage System Recall: Catheter Disconnection Risk (Jan. 22, 2024). Other recent recalls of similar products include Medline Convenience Kits: Open Seals Risk Patient Infection (July 31, 2026), Medline 5.5" Sterile Scissors Recall: Weak Packaging Risk of Infection (Nov. 13, 2025), and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).

How to tell if you have this one

Check for lot numbers 54984, 57188, 59558, 66312, or 67988 on the packaging. These Clip Gun Magazines come in sealed pouches inside boxes containing five units.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Packaging Seal
Inspect the pouch for any visible damage or breaches before use.

Where it went and when

Where it was distributed

Distributed in 37 states and D.C., and outside the U.S.

FDA distribution: “Domestic: AL, AZ, AR, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, LA, MD, MI, MN, MS, MO, NB, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY OUS: Australia, Germany, Kenya, Russian Federation, South Africa” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 4.3 years after the firm started it.

May 3, 2018Firm started the recall
Sep 21, 2018FDA classified it Class II
Oct 3, 2018Published in FDA’s Enforcement Report
Aug 30, 2022FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the recalled product?

The recall does not require immediate action, but you should check the packaging seal before use to ensure sterility.

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Link to this recall

<a href="https://govinfonow.com/recall/71212-medtronic-clip-gun-magazines-packaging-seal-risk">Medtronic Clip Gun Magazines: Packaging Seal 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-3212-2018 (May 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3212-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.