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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0352-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X3ENDIUU | Medtronic, Inc. | CBK | |
| Z-0351-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X2ESDIEC | Medtronic, Inc. | CBK | |
| Z-0350-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X1PLDIPC | Medtronic, Inc. | CBK | |
| Z-0349-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X1JADIJJ | Medtronic, Inc. | CBK | |
| Z-0348-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X1ENNISB | Medtronic, Inc. | CBK | |
| Z-0347-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X1ENDIUU | Medtronic, Inc. | CBK | |
| Z-0346-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980X1ENDIPC | Medtronic, Inc. | CBK | |
| Z-0345-2022 | Class I | Puritan Bennett 980 Series Ventilator,980X1ENAIQC | Medtronic, Inc. | CBK | |
| Z-0344-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980U3ESDIUU | Medtronic, Inc. | CBK | |
| Z-0343-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980U1ESDIUC | Medtronic, Inc. | CBK | |
| Z-0342-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980U1ENASAA | Medtronic, Inc. | CBK | |
| Z-0341-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980S3ENDICU | Medtronic, Inc. | CBK | |
| Z-0340-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980S1ENDICU | Medtronic, Inc. | CBK | |
| Z-0339-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980A3ENNISB | Medtronic, Inc. | CBK | |
| Z-0338-2022 | Class I | Puritan Bennett 980 Series Ventilator, 980A1ENNISB | Medtronic, Inc. | CBK | |
| Z-0295-2022 | Class II | Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by... | Medtronic Neuromodulation | LGW | |
| Z-0294-2022 | Class II | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by... | Medtronic Neuromodulation | MHY | |
| Z-0293-2022 | Class II | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by... | Medtronic Neuromodulation | EZW | |
| Z-0478-2022 | Class II | OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 | Haag-Streit USA Inc | OBO | |
| Z-0477-2022 | Class II | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 | Haag-Streit USA Inc | HLI | |
| Z-0412-2022 | Class II | Leica Microsystems M220 F12 Microscope Systems | Leica Microsystems, Inc. | FSO | |
| Z-0448-2022 | Class II | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with... | FLOWER ORTHOPEDICS Corporation dba Conventus Flower | HSB | |
| Z-0378-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998 | Medtronic, Inc. | FYA | |
| Z-0377-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578 | Medtronic, Inc. | FYA | |
| Z-0376-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 | Medtronic, Inc. | FYA | |
| Z-0375-2022 | Class II | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 | Medtronic, Inc. | FYA | |
| Z-0374-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070 | Medtronic, Inc. | FYA | |
| Z-0373-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040 | Medtronic, Inc. | FYA | |
| Z-0372-2022 | Class II | Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010 | Medtronic, Inc. | FYA | |
| Z-0371-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL | Medtronic, Inc. | FYA | |
| Z-0370-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041 | Medtronic, Inc. | FYA | |
| Z-0369-2022 | Class II | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 | Medtronic, Inc. | FYA | |
| Z-0368-2022 | Class II | SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474 | Medtronic, Inc. | FYA | |
| Z-0379-2022 | Class II | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V | OLYMPUS Corporation of the Americas | FDT | |
| Z-0318-2022 | Class II | The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN /... | Magnolia Medical Technologies, Inc. | JKA | |
| Z-0852-2022 | Class II | Hanger-Bar 2P 45cm | Human Care USA, Inc. | FSA | |
| Z-0851-2022 | Class II | Hanger-Bar 2P 45cm | Human Care USA, Inc. | FSA | |
| Z-0366-2022 | Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 | Smith & Nephew, Inc. | HRS | |
| Z-0365-2022 | Class II | smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 | Smith & Nephew, Inc. | HRS | |
| Z-0364-2022 | Class II | smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 | Smith & Nephew, Inc. | HRS | |
| Z-0363-2022 | Class II | smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 | Smith & Nephew, Inc. | HRS | |
| Z-0328-2022 | Class II | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and... | Randox Laboratories, Limited | CHH | |
| Z-1771-2022 | Class II | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u... | Diversatek Healthcare Inc | FGX | |
| Z-0476-2022 | Class II | Wireless Footswtich used with the following Philips Allura Xper and Azurion... | Philips North America LLC | OWB | |
| Z-0319-2022 | Class II | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model... | NuVasive Specialized Orthopedics, Inc. | HSB | |
| Z-2413-2024 | Class II | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device... | Palodex Group Oy | OAS | |
| Z-0400-2022 | Class II | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number... | Gyn-Disposables, Inc. | FPA | |
| Z-0335-2022 | Class II | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF... | Osteomed | KMW | |
| Z-0362-2022 | Class II | Bedside PICC CDS Convenience Kit | MEDLINE INDUSTRIES, LP - Northfield | OEZ | |
| Z-0361-2022 | Class II | Venous Access Pack-LF Convenience Kit | MEDLINE INDUSTRIES, LP - Northfield | OFF |