CLASS II ONGOING Device recall · Reported 30 Sep 2020 · FDA Enforcement Report
Speed Stitch Needle Cassette recalled by ArthroCare
ArthroCare is recalling Speed Stitch Needle Cassette, distributed nationwide in the US. The recall was initiated on 17 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2999-2020
- FDA event ID
- 86290
- Recalling firm
- ArthroCare, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Aug 2020
- FDA classified
- 21 Sep 2020
- Reported
- 30 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 17 Aug 2020 | Recall initiated by company | |
| 21 Sep 2020 | Classified by FDA | +35 days |
| 30 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Speed Stitch Needle Cassette
Where it was distributed
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, GB, HK, IE, PA, PR, PT, RU, SG, and ZA
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMaine
Questions about this recall
Is Speed Stitch Needle Cassette recalled?
Yes. ArthroCare recalled Speed Stitch Needle Cassette on 17 Aug 2020. The recall is Class II and its status is Ongoing. Recall number Z-2999-2020.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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, GB, HK, IE, PA, PR, PT, RU, SG, and ZA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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