Arctic Sun ArcticGel Pads — Class III medical device recall Z-0590-2018
Ongoing recall by C.R. Bard, Inc., reported 2017-12-13. Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the i
| Recall number | Z-0590-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-06-02 |
| Classified | 2018-02-12 |
| Reported by FDA | 2017-12-13 |
| Countries outside the US | AU, BE |
| Quantity | 128 units |
| Reason classes | labeling |
| Lot numbers | NGAR0462 |
Product
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Reason for recall
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
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-0590-2018. 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.