Open Heart Pack — Class II medical device recall Z-1139-2021
Terminated recall by DeRoyal Industries Inc, reported 2021-03-03, distributed in MI, OK, TX. Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile stic
| Recall number | Z-1139-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2021-01-25 |
| Classified | 2021-02-19 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-07-21 |
| Distributed | MI, OK, TX |
| Quantity | 1,084 packages |
| Reason classes | sterility |
| Lot numbers | 48535952, 48613789, 49330297, 49529669, 49852263, 50033361, 50404628, 50783200, 51021872, 51121460, 51284373, 51458898, 51701317, 51954402, 52183224, 52413069, 53117579, 53311005 |
| Expiration dates | 2021-03-01, 2021-07-01, 2021-08-01, 2021-09-01, 2021-11-01, 2021-12-01, 2022-04-01, 2022-04-30, 2022-07-01, 2022-09-01, 2022-10-01, 2022-11-01 |
Product
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Reason for recall
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
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-1139-2021. 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.