Puritan Bennett Cuff Pressure Manager — Class II medical device recall Z-2651-2023
Ongoing recall by Covidien, reported 2023-10-11, distributed in AL, AZ, CA, CO, FL, IL, KS, KY…. Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external p
| Recall number | Z-2651-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Boulder, CO, United States |
| Recall initiated | 2023-08-22 |
| Classified | 2023-09-29 |
| Reported by FDA | 2023-10-11 |
| Distributed | AL, AZ, CA, CO, FL, IL, KS, KY, MA, MI, NC, NJ, NY, TN, TX, UT |
| Countries outside the US | SE, SV |
| Quantity | 408 |
| UPC / GTIN / UDI-DI | 10884521782495 |
| Serial numbers | E223500003, E223500004, E223500005, E223500006, E223500007, E223500008, E223500009, E223500010, E223500011, E223500012, E223500013, E223500014, E223500015, E223500016, E223500017, E223500018, E223500019, E223500020, E223500021, E223500022, E223500023, E223500024, E223500025, E223500026, E223500027 and 383 more |
| Model numbers | 180-03 |
Product
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Reason for recall
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
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-2651-2023. 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.