Sep 30, 2026
Z-3240-2026
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera…
Philips North America Llc
- LNH
- 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
Sep 30, 2026
Z-3239-2026
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X),…
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3238-2026
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3237-2026
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3236-2026
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6.…
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3235-2026
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3234-2026
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3233-2026
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3232-2026
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achi…
Philips North America Llc
- LNH
- Class II
- Ongoing
Sep 30, 2026
Z-3231-2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux Inc
- LON
- Class II
- Ongoing
Sep 30, 2026
Z-3230-2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
Medline Industries, LP
- OGR
- Class II
- Ongoing
Sep 30, 2026
Z-3229-2026
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.
Medline Industries, LP
- LRO
- Class II
- Ongoing
Sep 30, 2026
Z-3226-2026
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
SEASPINE ORTHOPEDICS CORPORATION
- NKB
- Class II
- Ongoing
Sep 30, 2026
Z-3225-2026
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Fresenius Medical Care Renal Therapies Group, LLC
- FJK
- Class II
- Ongoing
Sep 30, 2026
Z-3224-2026
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Maquet SAS
- FSY
- Class II
- Ongoing
Sep 30, 2026
Z-3223-2026
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Ventec Life Systems, Inc.
- ECX
- Class II
- Ongoing
Sep 30, 2026
Z-3222-2026
REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver
Ventec Life Systems, Inc.
- ECX
- Class II
- Ongoing
Sep 30, 2026
Z-3221-2026
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Ventec Life Systems, Inc.
- ECX
- Class II
- Ongoing
Sep 30, 2026
Z-3220-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3219-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3218-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3217-2026
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturatio…
Midmark Corporation
- MWI
- Class II
- Ongoing
Sep 30, 2026
Z-3216-2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Olympus Corporation of the Americas
- FGE
- Class II
- Ongoing
Sep 30, 2026
Z-3215-2026
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform…
Heidelberg Engineering GmbH
- OBO
- Class II
- Ongoing
Sep 30, 2026
Z-3214-2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031…
Boston Scientific Corporation
- DQO
- Class I
- Ongoing