Custom surgical kits labeled as follows: — Class II medical device recall Z-0085-2018
Completed recall by Bioseal Corporation, reported 2017-11-15, distributed in CA, IL, NC, VT. Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline I
| Recall number | Z-0085-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bioseal Corporation, Placentia, CA, United States |
| Recall initiated | 2017-10-18 |
| Classified | 2017-11-09 |
| Reported by FDA | 2017-11-15 |
| Distributed | CA, IL, NC, VT |
| Quantity | 51,635 units |
| Reason classes | labeling |
| Lot numbers | 1137, 400346, 400348, 400349, 400351, 400354, 400355, 400356, 400361, 400362, 400364, 400366, 400367, 400369, 400370, 400372, 400373, 400376, 400380, 400385, 400386, 400389, 400392, 400393, 400394, 400395, 400396, 400397, 400399, 400401, 400402, 400403, 400407, 400408, 400413, 400414, 400416, 400417, 400418, 400419 and 10 more |
Product
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50
Reason for recall
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
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-0085-2018. 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.