Oct 7, 2026
Z-3296-2026
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVB…
Cardinal Health 200, LLC
- NWU
- 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 7, 2026
Z-3295-2026
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCB…
Cardinal Health 200, LLC
- LRO
- Class II
- Ongoing
Oct 7, 2026
Z-3294-2026
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP C…
American Contract Systems Inc
- OJF
- Class II
- Ongoing
Oct 7, 2026
Z-3293-2026
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0…
American Contract Systems Inc
- OEZ
- Class II
- Ongoing
Oct 7, 2026
Z-3292-2026
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
American Contract Systems Inc
- FDE
- Class II
- Ongoing
Oct 7, 2026
Z-3291-2026
Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing
Oct 7, 2026
Z-3290-2026
Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Ni…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing
Oct 7, 2026
Z-3289-2026
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile…
American Nitrile Operations Llc
- LZA
- Class II
- Ongoing
Oct 7, 2026
Z-3288-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3287-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3286-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3285-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3284-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3283-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Shanghai United Imaging Healthcare Co., Ltd.
- KPS
- Class II
- Ongoing
Oct 7, 2026
Z-3282-2026
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3281-2026
Computed Tomography X-ray System, Model: uCT ATLAS with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3280-2026
Computed Tomography X-ray System, Model: uCT 780 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3279-2026
Computed Tomography X-ray System, Model: uCT 760 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3278-2026
Computed Tomography X-ray System, Model: uCT 550 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3277-2026
Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare Co., Ltd.
- JAK
- Class II
- Ongoing
Oct 7, 2026
Z-3276-2026
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano Corp
- IYO
- Class II
- Ongoing
Oct 7, 2026
Z-3275-2026
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software
Bard Peripheral Vascular Inc
- KNW
- Class II
- Ongoing
Oct 7, 2026
Z-3274-2026
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing
Oct 7, 2026
Z-3273-2026
Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henr…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing
Oct 7, 2026
Z-3272-2026
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Hen…
Alere San Diego, Inc.
- JHI
- Class II
- Ongoing