PROLENE SUTURE 36" — Class II medical device recall Z-2462-2018
Terminated recall by Ethicon, Inc., reported 2018-07-25, distributed in AZ, CA, CO, FL, GA, IL, IN, KS…. The needle associated with certain suture product codes has the potential to perforate the packaging due to a
| Recall number | Z-2462-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-07-17 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2020-06-08 |
| Distributed | AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV |
| Quantity | 4,968 |
| Reason classes | sterility |
Product
PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
Reason for recall
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
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-2462-2018. 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.