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-0405-2016 | Class II | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-1678-2015 | Class II | KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code... | Halyard Health | BSY | |
| Z-1632-2015 | Class II | EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology... | Philips North America LLC | IYN | |
| Z-1631-2015 | Class II | EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology... | Philips North America LLC | IYN | |
| Z-1621-2015 | Class II | MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application... | bioMerieux, Inc. | N/A | |
| Z-1583-2015 | Class II | AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with... | Siemens Medical Solutions USA, Inc. | KPR | |
| Z-1620-2015 | Class II | The Integra Licox Pt02 Monitors are compact, portable device for use with... | Integra LifeSciences Corporation | GWM | |
| Z-1619-2015 | Class II | The Integra Licox Pt02 Monitors are compact, portable device for use with... | Integra LifeSciences Corporation | GWM | |
| Z-1618-2015 | Class II | The Integra Camino ICP Monitor is a compact, portable device for use with... | Integra LifeSciences Corporation | GWM | |
| Z-1543-2015 | Class II | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software... | Nihon Kohden America Inc | MHX | |
| Z-1824-2015 | Class II | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of... | CooperSurgical, Inc. | HIB | |
| Z-1670-2015 | Class II | SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-1669-2015 | Class II | SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-1668-2015 | Class II | SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2313-2015 | Class II | ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting... | The Anspach Effort, Inc. | HBE | |
| Z-2312-2015 | Class II | ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2311-2015 | Class II | ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting... | The Anspach Effort, Inc. | HBE | |
| Z-2310-2015 | Class II | ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2309-2015 | Class II | ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2308-2015 | Class II | ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping... | The Anspach Effort, Inc. | HBE | |
| Z-2307-2015 | Class II | ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping... | The Anspach Effort, Inc. | HBE | |
| Z-2306-2015 | Class II | ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-1666-2015 | Class II | Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device... | United Surgical LLC | IQI | |
| Z-2305-2015 | Class II | ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting... | The Anspach Effort, Inc. | HBE | |
| Z-1665-2015 | Class II | Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes... | United Surgical LLC | ITQ | |
| Z-2304-2015 | Class II | ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1... | The Anspach Effort, Inc. | HBE | |
| Z-1664-2015 | Class II | Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes... | United Surgical LLC | ITW | |
| Z-2303-2015 | Class II | ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2302-2015 | Class II | ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2301-2015 | Class II | ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2300-2015 | Class II | ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2299-2015 | Class II | ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and... | The Anspach Effort, Inc. | HBE | |
| Z-1695-2015 | Class II | Brilliance iCT Computed Tomography X-ray system | Philips North America LLC | JAK | |
| Z-2298-2015 | Class II | ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping... | The Anspach Effort, Inc. | HBE | |
| Z-2297-2015 | Class II | ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2296-2015 | Class II | ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2295-2015 | Class II | ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2294-2015 | Class II | ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2293-2015 | Class II | ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2292-2015 | Class II | ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping... | The Anspach Effort, Inc. | HBE | |
| Z-2291-2015 | Class II | ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2290-2015 | Class II | ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and... | The Anspach Effort, Inc. | HBE | |
| Z-2289-2015 | Class II | ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2288-2015 | Class II | ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2287-2015 | Class II | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2286-2015 | Class II | ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including... | The Anspach Effort, Inc. | HBE | |
| Z-2285-2015 | Class II | ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2284-2015 | Class II | ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and... | The Anspach Effort, Inc. | HBE | |
| Z-2283-2015 | Class II | ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone... | The Anspach Effort, Inc. | HBE | |
| Z-2282-2015 | Class II | ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping... | The Anspach Effort, Inc. | HBE |