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-0463-2019 | Class I | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001... | GE Healthcare | CBK | |
| Z-0509-2019 | Class II | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The... | Tosoh Bioscience Inc | KHO | |
| Z-0662-2019 | Class II | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per... | Abbott Medical | KRB | |
| Z-0661-2019 | Class II | Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3... | Abbott Medical | KRB | |
| Z-0601-2019 | Class III | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor... | Tosoh Bioscience Inc | LCP | |
| Z-0469-2019 | Class II | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience Inc | KHO | |
| Z-0372-2019 | Class II | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | Siemens Medical Solutions USA, Inc. | KPS | |
| Z-0236-2019 | Class II | SIGNA Architect system Product Usage: The Signa Architect system is a whole body... | GE Healthcare | LNH | |
| Z-0683-2019 | Class II | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx... | Medtronic, Inc. | OZO | |
| Z-0455-2019 | Class II | Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary... | Straumann USA, LLC | DZE | |
| Z-0956-2019 | Class II | AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0955-2019 | Class II | AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0954-2019 | Class II | AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0953-2019 | Class II | AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0952-2019 | Class II | AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0951-2019 | Class II | AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0950-2019 | Class II | AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0949-2019 | Class II | AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0948-2019 | Class II | AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Disposable... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0947-2019 | Class II | AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0946-2019 | Class II | AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0945-2019 | Class II | AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser Disposable... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0944-2019 | Class II | 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0943-2019 | Class II | AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0942-2019 | Class II | AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0941-2019 | Class II | AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0940-2019 | Class II | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain... | Arrow International LLC (subsidiary of Teleflex Incorporated) | MEB | |
| Z-0407-2019 | Class II | Medtronic CareLink Encore 29901 Programmer | Medtronic, Inc. | OSR | |
| Z-0406-2019 | Class II | Medtronic CareLink 2090 Programmer | Medtronic, Inc. | OSR | |
| Z-0454-2019 | Class II | Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0453-2019 | Class II | Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0452-2019 | Class II | Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0451-2019 | Class II | Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0450-2019 | Class II | Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0449-2019 | Class II | Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0448-2019 | Class II | Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0447-2019 | Class II | Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip... | Zimmer GmbH | HSB | |
| Z-0556-2019 | Class II | Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a)... | Pfizer Inc | IMD | |
| Z-0555-2019 | Class II | Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product... | Pfizer Inc | IMD | |
| Z-0554-2019 | Class II | Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product... | Pfizer Inc | IMD | |
| Z-0382-2019 | Class II | Liquid Cardiac Control, CQ5053 | Randox Laboratories, Limited | JJY | |
| Z-0381-2019 | Class II | Liquid Cardiac Control, CQ5052 | Randox Laboratories, Limited | JJY | |
| Z-0380-2019 | Class II | Liquid Cardiac Control, CQ5051 | Randox Laboratories, Limited | JJY | |
| Z-2106-2019 | Class II | YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for... | Comet Technologies USA Inc | RCE | |
| Z-2105-2019 | Class II | YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for... | Comet Technologies USA Inc | RCE | |
| Z-0705-2019 | Class II | MEVION S250i | Mevion Medical Systems, Inc. | LHN | |
| Z-0222-2020 | Class II | C3 Wave App, v. 2.0.5 | Medical Components, Inc. | LJS | |
| Z-0473-2019 | Class II | LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 | LeMaitre Vascular Inc. | MJN | |
| Z-0487-2019 | Class II | PremierPro Aluminum Adjustable Walker | SVS LLC | ITJ | |
| Z-0662-2020 | Class II | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge... | Paragon 28 | PLF |