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-0844-2010 | Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S... | Howmedica Osteonics Corp | HSB | ||
| Z-0843-2010 | Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S... | Howmedica Osteonics Corp | HSB | ||
| Z-0842-2010 | Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number... | Howmedica Osteonics Corp | HSB | ||
| Z-0841-2010 | Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number 18181030S... | Howmedica Osteonics Corp | HSB | ||
| Z-2888-2016 | Class II | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe... | SPIEGELBERG GmbH & Co. KG | GWM | |
| Z-1143-2010 | FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog #... | FHC, Inc. | GZL | ||
| Z-1235-2010 | CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths... | Abbott Medical | FRN | ||
| Z-0640-2010 | Exel Huber Infusion Set (Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R... | Exelint International Co. | FPA | ||
| Z-0639-2010 | Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S... | Exelint International Co. | FPA | ||
| Z-0638-2010 | Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE... | Exelint International Co. | FMI | ||
| Z-1175-2010 | Thermoflect Product Line including items for adults and pediatrics. | Encompass Group LLC | FME | ||
| Z-0796-2010 | Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in... | Howmedica Osteonics Corp | HTJ | ||
| Z-0779-2010 | Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports... | Zimmer GmbH | HWC | ||
| Z-0621-2010 | Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging... | GE Healthcare | MQB | ||
| Z-0620-2010 | Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system | GE Healthcare | MQB | ||
| Z-0619-2010 | Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray... | GE Healthcare | MQB | ||
| Z-0618-2010 | Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ... | GE Healthcare | MQB | ||
| Z-0617-2010 | Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System | GE Healthcare | MQB | ||
| Z-0616-2010 | Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose... | GE Healthcare | MQB | ||
| Z-2269-2010 | ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER... | Essential Medical Supply, Inc. | ITJ | ||
| Z-0979-2010 | Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd... | Remel Inc | JSC | ||
| Z-1810-2010 | Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic... | ZOLL Medical Corporation | MKJ | ||
| Z-0885-2011 | Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate... | Boston Scientific Corporation | DQY | ||
| Z-1101-2010 | AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF... | Abbott Medical | DQY | ||
| Z-1560-2010 | One Touch Ping Insulin Pump using ezManager Max diabetes management software | Animas Corp. | LZG | ||
| Z-1080-2010 | Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte | Medela AG | FPA | ||
| Z-1079-2010 | Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte | Medela AG | FPA | ||
| Z-1078-2010 | Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Medela AG | FPA | ||
| Z-1077-2010 | Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Medela AG | FPA | ||
| Z-1076-2010 | Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte | Medela AG | FPA | ||
| Z-3069-2011 | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model... | Applied Medical Resources Corp | GCJ | ||
| Z-3068-2011 | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model... | Applied Medical Resources Corp | GCJ | ||
| Z-3067-2011 | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model... | Applied Medical Resources Corp | GCJ | ||
| Z-3066-2011 | Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model... | Applied Medical Resources Corp | GCJ | ||
| Z-2178-2011 | Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic. | Siemens Healthcare Diagnostics Inc. | JIT | ||
| Z-0898-2010 | Electri-Cord Manufacturing Corporation(312 E. Main St., Westfield, PA 16950) AC power... | Arizant Healthcare, Inc. | DWJ | ||
| Z-0897-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power... | Arizant Healthcare, Inc. | DWJ | ||
| Z-0896-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power... | Arizant Healthcare, Inc. | DWJ | ||
| Z-0895-2010 | Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power... | Arizant Healthcare, Inc. | DWJ | ||
| Z-0661-2010 | Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away... | Merit Medical Systems, Inc. | DYB | ||
| Z-0828-2010 | RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin... | Microbiologics, Inc. | JSO | ||
| Z-0827-2010 | RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with... | Microbiologics, Inc. | JSO | ||
| Z-3272-2011 | VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; Manufactured by Maquet... | Maquet Cardiovascular LLC | GEI | ||
| Z-3271-2011 | VASOVIEW 7xB Endoscopic Vessel Harvesting System; Manufactured by Maquet Cardiovascular... | Maquet Cardiovascular LLC | GEI | ||
| Z-3270-2011 | VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular... | Maquet Cardiovascular LLC | GEI | ||
| Z-2385-2010 | Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension... | Siemens Healthcare Diagnostics Inc. | JMO | ||
| Z-0824-2010 | Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by... | Abiomed, Inc. | DSQ | ||
| Z-0922-2010 | DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951... | Diasorin Inc. | LFX | ||
| Z-0986-2011 | KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman... | King Systems Corporation. | CAE | ||
| Z-0985-2011 | KING LT -D Lanyngeal Tube, Size 3, KLTD203, King Systems Corporation 15011 Herriman... | King Systems Corporation. | CAE |