FDA Device recall Z-2651-2023
Puritan Bennett Cuff Pressure Manager, REF: 180-03
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Puritan Bennett Cuff Pressure Manager, REF: 180-03 by Covidien, citing 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 severa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2651-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-22 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | AL, AZ, CA, CO, FL, IL, KS, KY, MA, MI, NC, NJ, NY, TN, TX, UT |
Product
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Reason
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.
Identifiers
| code_info | UDI-DI: 10884521782495, Serial Numbers: E223500003, E223500004, E223500005, E223500006, E223500007, E223500008, E223500…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, E223500028, E223500029, E223500030, E223500031, E223500032, E223500054, E223500055, E223500079, E223500080, E223500081, E223500082, E223500083, E223600009, E223600010, E223600011, E223600012, E223600013, E223600014, E223600015, E223600016, E223600017, E223600018, E223600019, E223600020, E223600021, E223600022, E223600023, E223600024, E223600042, E223600070, E223600071, E223600072, E223600073, E223600074, E223600075, E223600076, E223600077, E223600078, E223600079, E223600080, E223600081, E223600082, E223600083, E223600084, E223600085, E223600086, E223600087, E223600088, E223600089, E223600090, E223600092, E223600093, E223600095, E223600096, E223600097, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2651-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.