Oct 28, 2026
Z-0204-2027
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Produc…
CooperVision, Inc.
- LPL
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Oct 28, 2026
Z-0203-2027
CareLink Clinic, REF: MMT-7350
Medtronic MiniMed, Inc.
- PHV
- Class II
- Ongoing
Oct 28, 2026
Z-0202-2027
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima…
Beckman Coulter, Inc.
- JQC
- Class II
- Ongoing
Oct 28, 2026
Z-0201-2027
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima…
Beckman Coulter, Inc.
- JQC
- Class II
- Ongoing
Oct 28, 2026
Z-0200-2027
Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with…
Greiner Bio-One North America, Inc.
- JKA
- Class II
- Ongoing
Oct 28, 2026
Z-0199-2027
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Philips North America
- MHX
- Class II
- Ongoing
Oct 28, 2026
Z-0198-2027
PNE Lead Implant Kit REF: 1701
Axonics, Inc.
- EZW
- Class II
- Ongoing
Oct 28, 2026
Z-0197-2027
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0196-2027
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0195-2027
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0194-2027
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0193-2027
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068.
B Braun Medical Inc
- FPA
- Class II
- Ongoing
Oct 28, 2026
Z-0192-2027
Think Surgical Square Driver REF: 109126
Think Surgical, Inc.
- OLO
- Class II
- Ongoing
Oct 28, 2026
Z-0191-2027
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-AC…
Abbott
- NGV
- Class II
- Ongoing
Oct 28, 2026
Z-0152-2027
Philips Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
- IYN
- Class I
- Ongoing
Oct 28, 2026
Z-0133-2027
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0132-2027
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0131-2027
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0130-2027
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0129-2027
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001, Package PN: N/A; Model Number: PRT-01185-002, Package PN:N/A. used fo…
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0128-2027
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0127-2027
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0126-2027
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0125-2027
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 28, 2026
Z-0124-2027
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing