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-0085-06 | Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black... | Surgical Specialties Corp | GAR | ||
| Z-0304-06 | Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time... | Siemens Healthcare Diagnostics Inc. | GGW | ||
| Z-0041-06 | Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS | Boston Scientific Corporation | FBK | ||
| Z-0040-06 | Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS | Boston Scientific Corporation | LNM | ||
| Z-0194-05 | Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD... | Boston Scientific Corporation | DXY | ||
| Z-0193-06 | Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and... | Boston Scientific Corporation | DXY | ||
| Z-0192-06 | Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190)... | Boston Scientific Corporation | DXY | ||
| Z-0191-06 | Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers... | Boston Scientific Corporation | DXY | ||
| Z-0092-06 | Sienet Cosmos. Radiological Image Processing. Model number 10018971 | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0190-06 | Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482)... | Boston Scientific Corporation | DXY | ||
| Z-0189-06 | Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194)... | Boston Scientific Corporation | DXY | ||
| Z-0188-06 | Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190)... | Boston Scientific Corporation | DXY | ||
| Z-0187-06 | Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers... | Boston Scientific Corporation | DXY | ||
| Z-0128-06 | Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink... | Rite-Dent Manufacturing Corp. | EHY | ||
| Z-0198-06 | High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional... | Canon Medical Systems USA, Inc. | JAA | ||
| Z-0031-06 | Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is... | Boston Scientific Corporation | GEI | ||
| Z-1375-06 | Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators | Varian Medical Systems, Inc. | IYE | ||
| Z-0125-06 | Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a... | Abbott Medical | DYB | ||
| Z-0083-06 | Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT | Medrad, Inc. | LHI | ||
| Z-0082-06 | Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT | Medrad, Inc. | LHI | ||
| Z-0269-06 | Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01... | Abbott Medical | GKZ | ||
| Z-1324-06 | Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Numbers... | Radiometer America, Inc | CHL | ||
| Z-1323-06 | Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number... | Radiometer America, Inc | CHL | ||
| Z-1191-06 | NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 | Respironics, Inc. | CBK | ||
| Z-0379-06 | V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic... | KCI USA, Inc. | JCX | ||
| Z-0305-06 | Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. | Invivo Corporation | MWI | ||
| Z-0197-06 | Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the... | Advanced Sterilization Products | MLR | ||
| Z-0063-06 | Tru-Link DIN unshielded ECG cable, 5-lead | GE Healthcare | DSI | ||
| Z-0104-06 | Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4 | Medical Components, Inc. | LJS | ||
| Z-0103-06 | Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number... | Medical Components, Inc. | LJS | ||
| Z-0003-06 | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. | B Braun Medical Inc | FRO | ||
| Z-0010-06 | ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access... | Abbott Medical | JJE | ||
| Z-0345-06 | Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 ***... | Oscor Inc. | DYB | ||
| Z-0084-06 | HoverMatt Patient Transfer Solution/Air Transfer Mattress | D.T. Davis Enterprises Ltd. | FRZ | ||
| Z-0102-06 | Accumetrics part number 29001 VerifyNow Instrument, printe power supply | Accumetrics, Inc. | JOZ | ||
| Z-0036-06 | FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring) | Analogic Corp. | HGM | ||
| Z-0002-06 | Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment... | Halyard Health | FXY | ||
| Z-0141-06 | Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz... | Integra LifeSciences Corporation | LFL | ||
| Z-0001-06 | Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use... | Halyard Health | FXY | ||
| Z-0035-06 | FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring) | Analogic Corp. | HGM | ||
| Z-0200-06 | Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-0139-06 | Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal... | Baxter Healthcare Renal Div | FKX | ||
| Z-0144-06 | D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use... | Vascular Solutions LLC | FRO | ||
| Z-0143-06 | D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device... | Vascular Solutions LLC | FRO | ||
| Z-0142-06 | D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device... | Vascular Solutions LLC | FRO | ||
| Z-1398-05 | Custom Procedure Trays, containing various configurations of medical and surgical... | Avid Medical, Inc. a Medical Action Ind. Company 305 | LRO | ||
| Z-0101-06 | Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed... | Lifescan, Inc. | CGA | ||
| Z-0564-06 | Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are... | Cygnus, LLC | JQC | ||
| Z-0339-06 | NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit | Natus Medical Incorporated | GWM | ||
| Z-0177-06 | Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter... | Datascope Corp. | DRT |