ArthroCare Corporation: Medical Device Recall in 2020 - (Recall #: Z-2999-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Speed Stitch Needle Cassette

Product Classification:

Class II

Date Initiated: August 17, 2020

Date Posted: September 30, 2020

Recall Number: Z-2999-2020

Event ID: 86290

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.

Status: Ongoing

Product Quantity: 6,366 needles

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated