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-1843-2011 | Ellex Tango LT5106-T ophthalmic laser (not sold in USA) | Ellex Medical Pty Ltd | HQF | ||
| Z-1842-2011 | Alcon 3000LE ophthalmic laser | Ellex Medical Pty Ltd | HQF | ||
| Z-1841-2011 | Ellex Ultra Q LQP3106-U ophthalmic laser | Ellex Medical Pty Ltd | HQF | ||
| Z-1840-2011 | Ellex Super Q LQP3106 ophthalmic laser | Ellex Medical Pty Ltd | HQF | ||
| Z-2022-2011 | i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a... | Abbott Medical | JGS | ||
| Z-2165-2011 | Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a... | Instrumentation Laboratory Co. | CGA | ||
| Z-1567-2011 | Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, Terumo... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1566-2011 | Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1646-2011 | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045... | Abbott Medical | FRN | ||
| Z-1645-2011 | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps... | Abbott Medical | FRN | ||
| Z-1644-2011 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps... | Abbott Medical | FRN | ||
| Z-1602-2011 | Hospira Plum XL3 Micro/Macro with DataPort Infusion Pump, Triple Channel, with a 0.1-999... | Abbott Medical | FRN | ||
| Z-1601-2011 | Hospira Plum XL3 Micro/Macro Infusion Pump, Triple Channel, with a 0.1-999 mL/hr flow... | Abbott Medical | FRN | ||
| Z-1600-2011 | Hospira Plum XL3 Infusion Pump, Triple Channel; list number 11781 | Abbott Medical | FRN | ||
| Z-1599-2011 | Hospira Plum XL Micro/Macro with DataPort Infusion Pump, Single Channel, with a 0.1-999... | Abbott Medical | FRN | ||
| Z-1598-2011 | Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate... | Abbott Medical | FRN | ||
| Z-1597-2011 | Hospira Plum XL Infusion Pump, Single Channel; list number 11555 | Abbott Medical | FRN | ||
| Z-1390-2011 | The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is... | Generic Medical Devices, Inc. | FTL | ||
| Z-2157-2011 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2148-2011 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2145-2011 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2172-2011 | UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2656-2011 | Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face... | Abbott Medical | BYF | ||
| Z-1866-2011 | HydroHydrofilm is for use as a post-operative and primary dressing to protect against... | Hartmann USA, Inc | MGP | ||
| Z-1822-2011 | Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee... | Ossur Engineering, Inc | ISY | ||
| Z-2655-2011 | First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6)... | Abbott Medical | BYF | ||
| Z-2654-2011 | First Breath Adult Face Tent with Tubing 188cm (5ft.) (Non-latex) Reorder Number... | Abbott Medical | BYG | ||
| Z-2653-2011 | First Breath Adult Face Tent (Non-latex) 50/CA Reorder Number: 001490 Face Tent Is a... | Abbott Medical | BYG | ||
| Z-2652-2011 | First Breath Pediatric Aerosol Mask (Non-Latex) 50/CA Reorder Number: 001476 For acute... | Abbott Medical | BYG | ||
| Z-2651-2011 | First Breath PEDIATRIC Medium Concentration Oxygen Mask with Tubing, 213cm (7ft)... | Abbott Medical | BYG | ||
| Z-2650-2011 | First Breath ADULT Elongated Non-Rebreather Oxygen Mask with 1L Reservoir Bag & Tubing... | Abbott Medical | BYG | ||
| Z-2649-2011 | First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 Oxygen/Aerosol... | Abbott Medical | BYG | ||
| Z-2648-2011 | First Breath 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft)... | Abbott Medical | BYG | ||
| Z-2647-2011 | First Breath Adult Oxygen Mask with Tubing, 213cm (7ft) Reorder Number... | Abbott Medical | BYG | ||
| Z-0176-2012 | BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection... | Becton Dickinson & Co | JKA | ||
| Z-1833-2011 | REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY... | Zimmer GmbH | FZX | ||
| Z-1589-2011 | Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141... | Zimmer GmbH | HRX | ||
| Z-1588-2011 | Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE | Zimmer GmbH | HRX | ||
| Z-1676-2011 | IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model... | AGFA Healthcare Corp. | LLZ | ||
| Z-3257-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726... | Abbott Medical | LPB | ||
| Z-3256-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725... | Abbott Medical | LPB | ||
| Z-3255-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724... | Abbott Medical | LPB | ||
| Z-2241-2011 | NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a... | Neusoft Medical Systems Co., Ltd. | JAK | ||
| Z-1396-2011 | Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko... | Hill-Rom Inc. | FSA | ||
| Z-1835-2011 | Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number... | Howmedica Osteonics Corp | |||
| Z-0518-2012 | The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE... | Intersurgical Ltd. | BSF | ||
| Z-2136-2011 | HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25... | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | IKD | ||
| Z-1664-2011 | LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part... | Jolife AB | DRM | ||
| Z-2230-2011 | Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH... | Deroyal Industries, Inc. Lafollette | LRP | ||
| Z-2229-2011 | Kits and Trays containing alcohol swabstick/prep pad: GEO-MED BIOPSY TRAY, V A MED CTR... | Deroyal Industries, Inc. Lafollette | LRP |