Oct 14, 2026
Z-0104-2027
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
AVID Medical, Inc.
- LRO
- 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 14, 2026
Z-0103-2027
UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0102-2027
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0101-2027
DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
AVID Medical, Inc.
- OKV
- Class II
- Ongoing
Oct 14, 2026
Z-0100-2027
PLASTICS TRAY; Model/Item Number (Kit): EURO053;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0099-2027
LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0098-2027
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
AVID Medical, Inc.
- OEZ
- Class II
- Ongoing
Oct 14, 2026
Z-0097-2027
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
AVID Medical, Inc.
- OEZ
- Class II
- Ongoing
Oct 14, 2026
Z-0096-2027
CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
AVID Medical, Inc.
- OJG
- Class II
- Ongoing
Oct 14, 2026
Z-0095-2027
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
AVID Medical, Inc.
- OEZ
- Class II
- Ongoing
Oct 14, 2026
Z-0094-2027
ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
AVID Medical, Inc.
- OEZ
- Class II
- Ongoing
Oct 14, 2026
Z-0093-2027
GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0092-2027
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
AVID Medical, Inc.
- LRO
- Class II
- Ongoing
Oct 14, 2026
Z-0091-2027
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Onkos Surgical, Inc.
- LPH
- Class II
- Ongoing
Oct 14, 2026
Z-0090-2027
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Onkos Surgical, Inc.
- LPH
- Class II
- Ongoing
Oct 14, 2026
Z-0089-2027
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06…
Nihon Kohden America LLC
- MHX
- Class II
- Ongoing
Oct 14, 2026
Z-0088-2027
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alt…
Medtronic MiniMed, Inc.
- QFG
- Class II
- Ongoing
Oct 14, 2026
Z-0087-2027
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support whi…
Medline Industries, LP
- ITJ
- Class II
- Ongoing
Oct 14, 2026
Z-0086-2027
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support…
Medline Industries, LP
- ITJ
- Class II
- Ongoing
Oct 14, 2026
Z-0085-2027
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Stryker Sustainability Solutions
- NLH
- Class II
- Ongoing
Oct 14, 2026
Z-0084-2027
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Oct 14, 2026
Z-0083-2027
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, D…
Beckman Coulter Inc.
- JJE
- Class II
- Ongoing
Oct 14, 2026
Z-0082-2027
Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
DRG International, Inc.
- DFQ
- Class II
- Ongoing
Oct 14, 2026
Z-0081-2027
Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Dra…
Safeguard US Operating LLC
- MHW
- Class II
- Ongoing
Oct 14, 2026
Z-0080-2027
Glypto Device, Glypto Cryo Machine;
Limitless Cryo Spa LLC
- GEH
- Class II
- Ongoing