Lower risk Medical device recall · FDA · Published August 17, 2020

ArthroCare Speed Stitch Needle Cassette Recall: Risk of Needle Breakage

ArthroCare recalls Speed Stitch Needle Cassette model OM-8850 with specific lot numbers due to potential needle breakage from improper material composition.

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

🇺🇸 FDA recall #Z-2999-2020Medical device ArthroCare ›

Lower-risk recall

Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

Take action

Contact the company

Recalling firmArthroCare Corporation7000 W William Cannon Dr Bldg 1 · Austin, TX 78735-8509

✎ GovInfoNow plain-language explainer

ArthroCare is recalling Speed Stitch Needle Cassettes (model OM-8850) with certain lot numbers because some needles may be made of titanium instead of 304 stainless steel. This could cause needles to break during use, potentially leading to injury. Read more at govinfonow.com/recall/64476-arthrocare-speed-stitch-needle-cassette-recall-risk-of-needle-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/64476-arthrocare-speed-stitch-needle-cassette-recall-risk-of-needle-breakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2999-2020

Cite this page

“ArthroCare Speed Stitch Needle Cassette Recall: Risk of Needle Breakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64476-arthrocare-speed-stitch-needle-cassette-recall-risk-of-needle-breakage. Based on FDA recall #Z-2999-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2999-2020%22&limit=1).

The FDA announced on Aug. 17, 2020, that ArthroCare Corporation voluntarily recalled 6,366 Speed Stitch Needle Cassettes due to a supplier error mixing raw materials. Some needles may be made of commercially pure titanium instead of the specified 304 stainless steel, posing a potential breakage risk during use.

How to tell if you have it

Brand: ArthroCare
Product: Speed Stitch Needle Cassette
Model: OM-8850
Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526

The hazard

According to the FDA, a supplier error caused a portion of raw material to be inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

Context

GovInfoNow's records show ArthroCare Corporation has 1 other recall on record since 2019-02-21. Other recent recalls of similar products include Smith&Nephew SmartStitch PerfectPasser Connector Recall (2019-02-21), B. Braun 21GA Winged Infusion Needle Recall (2026-02-02), Penumbra RED 62 Reperfusion Catheter Recall (2026-07-24), and Acumed Hexalob Screw Recall (2026-05-28).

How to tell if you have this one

Check the product label for model OM-8850 and lot numbers listed: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239, and 2032526.

Brand
ArthroCare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for model OM-8850 and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 42 states, and outside the U.S.

FDA distribution: “Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 44 days after the firm started it.

Aug 17, 2020Firm started the recall
Sep 21, 2020FDA classified it Class II
Sep 30, 2020Published in FDA’s Enforcement Report

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

Could using this product cause injury?

Yes, if needles break during use, it could lead to injury. However, the recall indicates this is a low-risk issue.

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Link to this recall

<a href="https://govinfonow.com/recall/64476-arthrocare-speed-stitch-needle-cassette-recall-risk-of-needle-breakage">ArthroCare Speed Stitch Needle Cassette Recall: Risk of Needle Breakage (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-2999-2020 (August 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2999-2020 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.