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-0821-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0820-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0819-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0818-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0817-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0816-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0815-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0814-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0813-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0812-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0811-2021 | Class II | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0519-2021 | Class II | MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET... | Bausch & Lomb Incorporated | MJP | |
| Z-0563-2021 | Class II | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest... | GE Healthcare | DQK | |
| Z-0634-2021 | Class II | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in... | Roche Diagnostics GmbH | DCN | |
| Z-1480-2022 | Class II | Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy... | Medtronic, Inc. | NIK | |
| Z-0510-2021 | Class II | ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog... | Veo Diagnostics, LLC | QMN | |
| Z-0615-2021 | Class II | RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec... | MEDLINE INDUSTRIES, LP - Northfield | NAB | |
| Z-0542-2021 | Class II | Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab... | K2M, Inc | LXH | |
| Z-2236-2021 | Class II | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use... | Neosteo | HTW | |
| Z-0637-2021 | Class II | EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS)... | Boston Scientific Corporation | KRA | |
| Z-0649-2021 | Class II | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve... | GA Health Company Limited | OCX | |
| Z-0648-2021 | Class II | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393... | GA Health Company Limited | OCX | |
| Z-0647-2021 | Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy... | GA Health Company Limited | OCX | |
| Z-0646-2021 | Class II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy... | GA Health Company Limited | OCX | |
| Z-0645-2021 | Class II | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter... | GA Health Company Limited | OCX | |
| Z-0644-2021 | Class II | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and... | GA Health Company Limited | OCX | |
| Z-0643-2021 | Class II | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and... | GA Health Company Limited | OCX | |
| Z-0642-2021 | Class II | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101... | GA Health Company Limited | OCX | |
| Z-0641-2021 | Class II | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R... | GA Health Company Limited | OCX | |
| Z-0640-2021 | Class II | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxili... | GA Health Company Limited | OCX | |
| Z-0639-2021 | Class II | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R... | GA Health Company Limited | OCX | |
| Z-0520-2021 | Class II | Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque... | K2M, Inc | NKG | |
| Z-0636-2021 | Class II | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa... | Kowa Pharmaceuticals America, Inc. | NFJ | |
| Z-0917-2021 | Class II | Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0916-2021 | Class II | Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0915-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to... | Respironics, Inc. | MNT | |
| Z-0914-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0913-2021 | Class II | Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to... | Respironics, Inc. | MNT | |
| Z-0912-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0911-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0910-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0909-2021 | Class II | Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0908-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0907-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0906-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0905-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0904-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0903-2021 | Class II | Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be... | Respironics, Inc. | MNT | |
| Z-0772-2021 | Class II | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur... | Smith & Nephew, Inc. | JDS | |
| Z-0539-2021 | Class II | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage... | Chromsystems Instruments & Chemicals GmbH | JJY |