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-0721-2012 | Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0720-2012 | Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0719-2012 | Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-0718-2012 | Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm... | Angiodynamics Worldwide Headquarters | MSD | ||
| Z-1816-2012 | Class II | Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325... | Howmedica Osteonics Corp | GAC | |
| Z-1982-2012 | Class II | Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through... | Howmedica Osteonics Corp | JDI | |
| Z-1358-2012 | Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral... | Gendex Corp. | EHD | ||
| Z-0941-2012 | DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part... | Canon Medical Systems USA, Inc. | MQB | ||
| Z-0929-2012 | Product is a lithium ion battery sold as both a stand-alone accessory, and as part of... | Cogentix Medical, Inc. | EOB | ||
| Z-0928-2012 | Product is a lithium ion battery charger sold as both a stand-alone accessory, and as... | Cogentix Medical, Inc. | EOB | ||
| Z-0829-2012 | Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and... | OLYMPUS Corporation of the Americas | KNS | ||
| Z-0828-2012 | Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22066A and... | OLYMPUS Corporation of the Americas | KNS | ||
| Z-0825-2012 | Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic... | Fresenius Medical Care Renal Therapies Group, LLC | KDI | ||
| Z-1220-2012 | DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional... | Philips North America LLC | JAA | ||
| Z-1565-2014 | Class II | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral... | SPINEFRONTIER, Inc. dba LESspine Innovations | MAX | |
| Z-1618-2012 | Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica... | Howmedica Osteonics Corp | HTO | ||
| Z-1399-2012 | GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW... | GE Healthcare | IZL | ||
| Z-0926-2012 | Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health... | Medtronic, Inc. | LRO | ||
| Z-0925-2012 | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal... | Medtronic, Inc. | LRO | ||
| Z-0834-2012 | GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician... | GE Healthcare | IYN | ||
| Z-2396-2012 | Class II | Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976... | United States Endoscopy Group, Inc. | KOG | |
| Z-2084-2012 | Class II | Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics... | Howmedica Osteonics Corp | LXH | |
| Z-2099-2012 | Class II | Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured... | Church & Dwight Co., Inc. | JEQ | |
| Z-2098-2012 | Class II | Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church... | Church & Dwight Co., Inc. | JEQ | |
| Z-2097-2012 | Class II | Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church... | Church & Dwight Co., Inc. | JEQ | |
| Z-2096-2012 | Class II | Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for... | Church & Dwight Co., Inc. | JEQ | |
| Z-2095-2012 | Class II | Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in... | Church & Dwight Co., Inc. | JEQ | |
| Z-2094-2012 | Class II | Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in... | Church & Dwight Co., Inc. | JEQ | |
| Z-2093-2012 | Class II | Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured... | Church & Dwight Co., Inc. | JEQ | |
| Z-1363-2012 | Servo-s ventilator system Product Usage: Intended for treatment and monitoring of... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-1362-2012 | Servo-i ventilator system Product Usage: Intended for treatment and monitoring of... | Maquet Cardiovascular Us Sales, LLC | CBK | ||
| Z-0934-2012 | Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX... | Imalux Corporation | NQQ | ||
| Z-0712-2012 | Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size... | Adenna Inc | LYY | ||
| Z-0859-2012 | Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in... | Church & Dwight Co., Inc. | JEQ | |
| Z-0858-2012 | Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in... | Church & Dwight Co., Inc. | JEQ | |
| Z-0857-2012 | Class II | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made... | Church & Dwight Co., Inc. | JEQ | |
| Z-1147-2012 | Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix... | Integra LifeSciences Corporation | HRS | ||
| Z-1045-2012 | SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell... | bioMerieux, Inc. | JWX | ||
| Z-1042-2012 | Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F... | Leica Microsystems, Inc. | ETP | ||
| Z-0938-2012 | KIMBERLY CLARK MIC GASTRO-ENTERIC FEEDING TUBE, 22F. Gastro-Enteric Feeding Tube. | Kimberly-Clark Corporation | KNT | ||
| Z-0855-2012 | Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II... | Zimmer GmbH | JWH | ||
| Z-0854-2012 | Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm The Zimmer Natural-Knee II... | Zimmer GmbH | JWH | ||
| Z-0853-2012 | Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II... | Zimmer GmbH | JWH | ||
| Z-0852-2012 | Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm The Zimmer Natural-Knee II... | Zimmer GmbH | JWH | ||
| Z-0851-2012 | Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul... | Zimmer GmbH | JWH | ||
| Z-0850-2012 | Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm The Zimmer Natural-Knee II Durasul... | Zimmer GmbH | JWH | ||
| Z-0849-2012 | Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul... | Zimmer GmbH | JWH | ||
| Z-0848-2012 | Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul... | Zimmer GmbH | JWH | ||
| Z-0759-2012 | Cranial Access Kit Ref HITHSP06 Integra NeuroSciences Plainsboro, NJ 08536 Sterile and... | Integra Pain Management | HBG | ||
| Z-0758-2012 | 1104BC Combo Kit including 1 Cranial Kit w/Cam Chuck, 1 OLM Intracranial Pressure... | Integra Pain Management | HBG |