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-0214-06 | CryoValve, Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0213-06 | CryoValve, Aortic Valve | Artivion, Inc. | MIE | ||
| Z-0212-06 | CryoValve, Alt Pulmonary Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0211-06 | CryoValve, Alt Pulmonary Valve | Artivion, Inc. | MIE | ||
| Z-0210-06 | CryoValve, Alt Aortic Valve & Conduit | Artivion, Inc. | MIE | ||
| Z-0292-04 | Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000 | Maquet Cardiovascular LLC | HET | ||
| Z-0305-04 | Pentalumen TD Thermodilution Catheter, Sterile | Abbott Medical | DYG | ||
| Z-0265-04 | Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software | Medtronic, Inc. | LZG | ||
| Z-0268-04 | Bucky Diagnost FS Part number 9890-010-83651 | Philips North America LLC | KPR | ||
| Z-0229-04 | ISPAN patient bracelet, given to patients post surgery to warn of further use of... | Alcon Laboratories | LPO | ||
| Z-0887-05 | LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part... | Lifescan, Inc. | CGA | ||
| Z-0357-04 | Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial... | Coherent, Inc. | -- | ||
| Z-0325-04 | TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label... | Abbott Diagnostic International, Ltd. | LFG | ||
| Z-0324-04 | ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx... | Abbott Diagnostic International, Ltd. | LFH | ||
| Z-0323-04 | AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM... | Abbott Diagnostic International, Ltd. | LDM | ||
| Z-0280-04 | Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number... | Abbott Medical | LGQ | ||
| Z-0279-04 | Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number... | Abbott Medical | LEH | ||
| Z-0278-04 | Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers... | Abbott Medical | LCD | ||
| Z-0277-04 | Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number... | Abbott Medical | KLT | ||
| Z-0263-04 | The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories... | Abbott Medical | JQP | ||
| Z-0262-04 | The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories... | Abbott Medical | JQP | ||
| Z-0266-04 | Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL... | Medtronic, Inc. | HAP | ||
| Z-0206-04 | Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A. | Hill-Rom Inc. | KMM | ||
| Z-0290-04 | Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message... | Minolta Corp | DQA | ||
| Z-0289-04 | Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message... | Minolta Corp | DQA | ||
| Z-0205-04 | Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown Mueller T-Fastener Set, Item... | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0204-04 | Ross 22 FR Versa-PEG Gastrostomy Kit, Item #50520. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0203-04 | Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #50190. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0202-04 | Ross 28 FR Magna-Port Gastrostomy Tube, Item #54736. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0201-04 | Ross 24 FR Magna-Port Gastrostomy Tube, Item #54738. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0200-04 | Ross 22 FR Magna-Port Gastrostomy Tube, Item #51366. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0199-04 | Ross 20 FR Magna-Port Gastrostomy Tube, Item #51364. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0198-04 | Ross 18 FR Magna-Port Gastrostomy Tube, Item #51362. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0197-04 | Ross 16 FR Magna-Port Gastrostomy Tube, Item #51360. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0196-04 | Ross 14 FR Magna-Port Gastrostomy Tube, Item #51358. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0195-04 | Ross 22 FR Easy-Feed Gastrostomy Tube, Item #50118. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0194-04 | Ross 20 FR Easy-Feed Gastrostomy Tube, Item #50116. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0193-04 | Ross 18 FR Easy-Feed Gastrostomy Tube, Item #50114. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0192-04 | Ross 16 FR Easy-Feed Gastrostomy Tube, Item #50112. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0191-04 | Ross 26 FR Gastrostomy Tube, Item #50158. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0190-04 | Ross 24 FR Gastrostomy Tube, Item #159. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0189-04 | Ross 22 FR Gastrostomy Tube, Item #156. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0188-04 | Ross 20 FR Gastrostomy Tube, Item #155. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0187-04 | Ross 18 FR Gastrostomy Tube, Item #154. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0186-04 | Ross 16 FR Gastrostomy Tube, Item #153. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0185-04 | Ross 14 FR Gastrostomy Tube, Item #152. | Ross Products Division Abbott Laboratories | KNT | ||
| Z-0230-04 | IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott... | Abbott Medical | MLM | ||
| Z-0294-04 | LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the... | Physio Control, Inc. | MKI | ||
| Z-0171-04 | Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number... | Stryker Corp. | FPK | ||
| Z-0228-04 | Model LightLas 532 Opthalmic Photocoagulator Laser | Light-Med (USA), Inc. | HQF |