Speed Stitch Needle Cassette — Class II medical device recall Z-2999-2020
Ongoing recall by ArthroCare Corporation, reported 2020-09-30, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles
| Recall number | Z-2999-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ArthroCare Corporation, Austin, TX, United States |
| Recall initiated | 2020-08-17 |
| Classified | 2020-09-21 |
| Reported by FDA | 2020-09-30 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Quantity | 6,366 needles |
| Reason classes | device malfunction |
| Lot numbers | 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2032526, 2033815, 2036941, 2037604, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 |
| Model numbers | OM-8850 |
Product
Speed Stitch Needle Cassette
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2999-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.