20/30 INDEFLATOR -REF 1000184 WPL2122268-01 — Class II medical device recall Z-0921-2022
Ongoing recall by Abbott Vascular, reported 2022-04-20, distributed nationwide. Due to an increase in complaint trend for leaks and intermittent/loose connections.
| Recall number | Z-0921-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2022-03-11 |
| Classified | 2022-04-13 |
| Reported by FDA | 2022-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DO, ES, FR, GB, GR, ID, IL, IN, IT, JM, JP, KR, LU, MX, NL, NZ, PA, PK, PT, RO, SA, SG, SK, TH, TW, UY, VN, ZA |
| Quantity | 17 lots |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08717648013591 |
| Lot numbers | 60309678, 60311336, 60311337, 60311338, 60311339, 60315914, 60317535, 60317539, 60318209, 60320071, 60320899, 60331726, 60331727, 60334491, 60334492, 60337162, 60337166 |
| Model numbers | 1000184, WPL2122268-01 |
Product
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Reason for recall
Due to an increase in complaint trend for leaks and intermittent/loose connections.
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-0921-2022. 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.