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-1003-2019 | Class II | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt... | Ossur Americas | KQZ | |
| Z-1002-2019 | Class II | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J... | Ossur Americas | HAX | |
| Z-1001-2019 | Class II | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT... | Ossur Americas | HAX | |
| Z-1000-2019 | Class II | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT... | Ossur Americas | HAX | |
| Z-0999-2019 | Class II | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING... | Ossur Americas | HAX | |
| Z-0998-2019 | Class II | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in... | Ossur Americas | LYT | |
| Z-0464-2019 | Class II | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery... | Advanced Medical Optics, Inc. | HQL | |
| Z-2785-2018 | Class II | Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This... | Degania Silicone, Inc. | EZL | |
| Z-2784-2018 | Class II | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This... | Degania Silicone, Inc. | EZL | |
| Z-2783-2018 | Class II | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This... | Degania Silicone, Inc. | EZL | |
| Z-2782-2018 | Class II | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This... | Degania Silicone, Inc. | EZL | |
| Z-2781-2018 | Class II | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This... | Degania Silicone, Inc. | EZL | |
| Z-2780-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product... | Degania Silicone, Inc. | EZL | |
| Z-2779-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product... | Degania Silicone, Inc. | EZL | |
| Z-2778-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product... | Degania Silicone, Inc. | EZL | |
| Z-2777-2018 | Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product... | Degania Silicone, Inc. | EZL | |
| Z-2776-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2775-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2774-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2773-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2772-2018 | Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2771-2018 | Class II | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product... | Degania Silicone, Inc. | EZL | |
| Z-2770-2018 | Class II | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product... | Degania Silicone, Inc. | EZL | |
| Z-2769-2018 | Class II | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product... | Degania Silicone, Inc. | EZL | |
| Z-2768-2018 | Class II | Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product... | Degania Silicone, Inc. | EZL | |
| Z-2767-2018 | Class II | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2766-2018 | Class II | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2765-2018 | Class II | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2764-2018 | Class II | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2763-2018 | Class II | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number... | Degania Silicone, Inc. | EZL | |
| Z-2762-2018 | Class II | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2761-2018 | Class II | Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2760-2018 | Class II | Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2759-2018 | Class II | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2758-2018 | Class II | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2757-2018 | Class II | Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is... | Degania Silicone, Inc. | EZL | |
| Z-2756-2018 | Class II | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product... | Degania Silicone, Inc. | EZL | |
| Z-2755-2018 | Class II | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product... | Degania Silicone, Inc. | EZL | |
| Z-2754-2018 | Class II | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product... | Degania Silicone, Inc. | EZL | |
| Z-2869-2018 | Class II | BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing... | Becton Dickinson & Co | JTY | |
| Z-0997-2019 | Class II | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI... | Ossur Americas | JEC | |
| Z-2415-2018 | Class II | Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are... | Medtronic, Inc. | NKE | |
| Z-2414-2018 | Class II | Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable... | Medtronic, Inc. | NKE | |
| Z-2413-2018 | Class II | Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are... | Medtronic, Inc. | NKE | |
| Z-2412-2018 | Class II | Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable... | Medtronic, Inc. | NKE | |
| Z-2421-2018 | Class II | Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable... | Medtronic, Inc. | LWS | |
| Z-2420-2018 | Class II | Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable... | Medtronic, Inc. | LWS | |
| Z-2419-2018 | Class II | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and... | Medtronic, Inc. | LWS | |
| Z-2418-2018 | Class II | Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and... | Medtronic, Inc. | LWS | |
| Z-2417-2018 | Class II | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and... | Medtronic, Inc. | LWS |