Pfizer Inc
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
Devices registered here (1)
- Medical Device Data SystemProduct code OUG (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6310
Recalls & enforcement
- Class IITerminated2018-10-02The firm received complaints of the wrap coming apart and leaking granular material
- Class IITerminated2016-12-30Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an …
- Class IITerminated2016-07-28Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.
Related
- All facilities operated by PFIZER INC.
- Pfizer Manufacturing Belgium NV (BE)
- Wyeth Pharmaceuticals LLC (PA)
- HOSPIRA, INC. (KS)
- PHARMACIA & UPJOHN COMPANY LLC (MI)
- Pfizer Service Company BV (BE)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Pfizer Inc (FEI 3004945409) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004945409-pfizer-inc/
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