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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 177 of 1190
FDA device recalls, page 177 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0349-2024Class IIBD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set...Becton Dickinson & CoFPA
Z-0369-2024Class IIMedline manual resuscitators with integrated manometer, multiple accessory configurations...Salter LabsBTM
Z-0368-2024Class IICuraplex manual resuscitators with integrated manometer, multiple accessory...Salter LabsBTM
Z-0367-2024Class IIVentlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory...Salter LabsBTM
Z-0366-2024Class IIVentlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple...Salter LabsBTM
Z-0365-2024Class IIVentlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory...Salter LabsBTM
Z-0364-2024Class IIVentlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory...Salter LabsBTM
Z-0363-2024Class IIVentlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory...Salter LabsBTM
Z-0362-2024Class IIVentlab, LLC BreathTech manual resuscitators with integrated manometer, multiple...Salter LabsBTM
Z-0361-2024Class IIVentlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple...Salter LabsBTM
Z-0633-2024Class IIXstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025Becton Dickinson & CoHNN
Z-0441-2024Class IIAutomated Impella Controller (AIC), product number 0042-040-US with software versions...Abiomed, Inc.OZD
Z-0440-2024Class IIAutomated Impella Controller (AIC), product number 0042-000-US with software versions...Abiomed, Inc.OZD
Z-0507-2024Class IIStay Safe CapFresenius Medical Care Renal Therapies Group, LLCKDJ
Z-0547-2024Class IIVITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0Ortho-Clinical Diagnostics, Inc.JJE
Z-0546-2024Class IIVITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0Ortho-Clinical Diagnostics, Inc.JJE
Z-0545-2024Class IIVITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915...Ortho-Clinical Diagnostics, Inc.JJE
Z-0544-2024Class IIVITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440...Ortho-Clinical Diagnostics, Inc.JJE
Z-0543-2024Class IIVITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code...Ortho-Clinical Diagnostics, Inc.JJE
Z-0420-2024Class ICARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System...Maquet Cardiovascular Us Sales, LLCDTQ
Z-0306-2024Class IISpectral CT on Rails, Software Version 5.1.0, Model Number 728334Philips North America LLCJAK
Z-0319-2024Class IISpectral CT on Rails, Software Version 5.1.0, Model Number 728334Philips North America LLCJAK
Z-0388-2024Class IICompress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0387-2024Class IICompress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0386-2024Class IICompress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0385-2024Class IICompress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0384-2024Class IICompress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0383-2024Class IICompress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0382-2024Class IICompress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0381-2024Class IICompress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0380-2024Class IICompress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0379-2024Class IICompress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0378-2024Class IICompress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0377-2024Class IICompress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0376-2024Class IICompress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0375-2024Class IICompress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0374-2024Class IICompress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0373-2024Class IICompress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0372-2024Class IICompress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0371-2024Class IICompress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0370-2024Class IICompress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful...Zimmer GmbHKWA
Z-0294-2024Class IIBrilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT...Philips North America LLCJAK
Z-0293-2024Class IIBrilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and...Philips North America LLCJAK
Z-0292-2024Class IIBig Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator...Philips North America LLCJAK
Z-0284-2024Class IIPhilips Affiniti 70, Diagnostic Ultrasound System Model # 795210Philips North America LLCIYN
Z-0283-2024Class IIPhilips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C...Philips North America LLCIYN
Z-0095-2024Class IIMED-810A Zemits NDPrime Laser productsAdvance-Esthetic LLCGEX
Z-1279-2024Class IID-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.Peter Lazic GmbHHCI
Z-1278-2024Class IID-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.Peter Lazic GmbHHCI
Z-1277-2024Class IID-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.Peter Lazic GmbHHCI