DR — Class II medical device recall Z-2160-2020
Terminated recall by Applied Medical Resources Corp, reported 2020-06-03, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential
| Recall number | Z-2160-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2020-03-17 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-02-17 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AR, AT, AU, BE, CA, CL, CR, DE, DK, ES, FR, GB, GR, HK, IE, IL, IN, IT, LU, LV, NL, NZ, PE, PT, RS, SG, TH, ZA |
| Quantity | 21 units |
| UPC / GTIN / UDI-DI | 30607915139620 |
| Lot numbers | 1378830, 1379253, 1380094, 1381695 |
| Model numbers | K0880 |
| Expiration dates | 2022-08-13, 2022-08-22, 2022-09-08, 2022-10-30 |
Product
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Reason for recall
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
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-2160-2020. 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.