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-2735-2016 | Class II | BrightView X, model #882478; gamma camera designed for single or dual detector nuclear... | Philips North America LLC | KPS | |
| Z-2100-2016 | Class II | LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are... | Physio Control, Inc. | MKJ | |
| Z-2833-2016 | Class II | TriFoillmaging Triumph/Triumph II Research CT scanners. | Northridge Tri-Modality Imaging | JAK | |
| Z-2119-2016 | Class III | VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in... | Ortho-Clinical Diagnostics, Inc. | JMO | |
| Z-2146-2016 | Class II | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains... | Hardy Diagnostics | KPA | |
| Z-2081-2016 | Class II | CENTURION Vision System | Alcon Laboratories | HQC | |
| Z-2044-2016 | Class II | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor... | Fresenius Medical Care Renal Therapies Group, LLC | KOC | |
| Z-2586-2016 | Class II | TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single... | Synthes (USA) Products LLC | MQN | |
| Z-2585-2016 | Class II | TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single... | Synthes (USA) Products LLC | MQN | |
| Z-2584-2016 | Class II | TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium... | Synthes (USA) Products LLC | MQN | |
| Z-2583-2016 | Class II | TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium... | Synthes (USA) Products LLC | MQN | |
| Z-2582-2016 | Class II | TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium... | Synthes (USA) Products LLC | MQN | |
| Z-2581-2016 | Class II | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium... | Synthes (USA) Products LLC | MQN | |
| Z-2246-2016 | Class II | DeVilbiss Model 7305P-D Powered Suction Unit | Sunrise Medical, Inc. | JCX | |
| Z-2048-2016 | Class II | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide... | Medtronic, Inc. | NIP | |
| Z-2248-2016 | Class II | OT1000 Series Orthopedic Surgical Tables | STERIS Corporation | JEA | |
| Z-2049-2016 | Class II | PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy | Baxter Healthcare Corporation | KPO | |
| Z-2607-2016 | Class II | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz... | Merz North America, Inc. | LMH | |
| Z-2249-2016 | Class II | Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. | Amerx Health Care Corp. | KMJ | |
| Z-2042-2016 | Class II | Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N | SSC- Surgical Specialties Corporation | GAW | |
| Z-2084-2016 | Class II | K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw... | Integra LifeSciences Corporation | HXI | |
| Z-1398-2017 | Class II | Toshiba Ultimax DREX-ULT80 X-ray generator | Canon Medical Systems USA, Inc. | JAA | |
| Z-1397-2017 | Class II | Toshiba Kalare DREX-KL80 X-ray generator | Canon Medical Systems USA, Inc. | JAA | |
| Z-2608-2016 | Class II | Conical portio adapter (acorn) small & large are used for examination and diagnosis in... | Richard Wolf Medical Instruments Corp. | HHI | |
| Z-2211-2016 | Class II | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each... | Devicor Medical Products Inc | OIJ | |
| Z-2046-2016 | Class II | 6534-08N InterActive Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product... | Implant Direct Sybron Manufacturing LLC | EHY | |
| Z-2672-2017 | Class II | Proteus 235 and Proteus ONE proton therapy systems | Ion Beam Applications S.A. | LHN | |
| Z-2599-2016 | Class II | Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad... | ConMed Corporation | GEI | |
| Z-0289-2017 | Class II | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile... | United States Endoscopy Group, Inc. | FBK | |
| Z-2273-2016 | Class II | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device... | Ortho-Clinical Diagnostics, Inc. | CJY | |
| Z-2598-2016 | Class II | Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad... | ConMed Corporation | GEI | |
| Z-2597-2016 | Class II | Pediatric ThermoGard Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m)... | ConMed Corporation | GEI | |
| Z-2596-2016 | Class II | Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog... | ConMed Corporation | GEI | |
| Z-2595-2016 | Class II | Adult ThermoGard Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable... | ConMed Corporation | GEI | |
| Z-1879-2016 | Class II | Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for... | Elekta Limited | MUJ | |
| Z-2241-2016 | Class II | Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878... | CSL Behring LLC | LPS | |
| Z-0127-2017 | Class II | Calix T PEEK Lumbar System, TLIF Trial | Xtant Medical Holdings, Inc. | MAX | |
| Z-0126-2017 | Class II | Calix T PEEK Lumbar System, TLIF Rasp | Xtant Medical Holdings, Inc. | MAX | |
| Z-0125-2017 | Class II | Calix P PEEK Lumbar System, PLIF Trial | Xtant Medical Holdings, Inc. | MAX | |
| Z-0124-2017 | Class II | Calix P PEEK Lumbar System, PLIF Rasp | Xtant Medical Holdings, Inc. | MAX | |
| Z-1956-2016 | Class II | Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-2003-2016 | Class II | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System... | Zimmer GmbH | KWS | |
| Z-2203-2016 | Class III | cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B... | Roche Molecular Systems Inc | OCC | |
| Z-1899-2016 | Class I | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control... | Jaeger Medical GmbH | CBK | |
| Z-1898-2016 | Class I | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically... | Jaeger Medical GmbH | CBK | |
| Z-1897-2016 | Class I | Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to... | Jaeger Medical GmbH | CBK | |
| Z-1896-2016 | Class I | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically... | Jaeger Medical GmbH | CBK | |
| Z-1895-2016 | Class I | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended... | Jaeger Medical GmbH | CBK | |
| Z-1894-2016 | Class I | TCA Board, 16542A A continuous ventilator intended to mechanically control or assist... | Jaeger Medical GmbH | CBK | |
| Z-1893-2016 | Class I | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous... | Jaeger Medical GmbH | CBK |