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-2205-2018 | Class II | RS 5F DL BIOFLO PASV, Catalog Number 60M132324 | Boston Scientific Corporation | LJS | |
| Z-2204-2018 | Class II | RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196 | Boston Scientific Corporation | LJS | |
| Z-2203-2018 | Class II | RS 5F DL BIOFLO PICC, Catalog Number 60M071831 | Boston Scientific Corporation | LJS | |
| Z-2202-2018 | Class II | RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472 | Boston Scientific Corporation | FOZ | |
| Z-2201-2018 | Class II | RS 5F DL XPP, Catalog Number 60M030393 | Boston Scientific Corporation | LJS | |
| Z-2200-2018 | Class II | RS TANDEM 5F DL XPP, Catalog Number 60M019881 | Boston Scientific Corporation | LJS | |
| Z-2199-2018 | Class II | BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810 | Boston Scientific Corporation | FOZ | |
| Z-2198-2018 | Class II | BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG... | Boston Scientific Corporation | FOZ | |
| Z-2197-2018 | Class II | Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 | Boston Scientific Corporation | DYB | |
| Z-2196-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number... | Boston Scientific Corporation | LJS | |
| Z-2195-2018 | Class II | Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG, Catalog Number 45-892 | Boston Scientific Corporation | LJS | |
| Z-2194-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887 | Boston Scientific Corporation | LJS | |
| Z-2193-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886 | Boston Scientific Corporation | LJS | |
| Z-2192-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882 | Boston Scientific Corporation | LJS | |
| Z-2191-2018 | Class II | Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872 | Boston Scientific Corporation | LJS | |
| Z-2190-2018 | Class II | Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871 | Boston Scientific Corporation | LJS | |
| Z-2189-2018 | Class II | Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818 | Boston Scientific Corporation | LJS | |
| Z-2188-2018 | Class II | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 | Boston Scientific Corporation | LJS | |
| Z-2359-2018 | Class II | microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), | FHC, Inc. | HAW | |
| Z-2358-2018 | Class II | microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number... | FHC, Inc. | HAW | |
| Z-2357-2018 | Class II | microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number... | FHC, Inc. | HAW | |
| Z-2356-2018 | Class II | microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 | FHC, Inc. | HAW | |
| Z-2355-2018 | Class II | microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 | FHC, Inc. | HAW | |
| Z-2354-2018 | Class II | microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB | FHC, Inc. | HAW | |
| Z-2353-2018 | Class II | microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB | FHC, Inc. | HAW | |
| Z-2352-2018 | Class II | microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME | FHC, Inc. | HAW | |
| Z-2351-2018 | Class II | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA | FHC, Inc. | HAW | |
| Z-2350-2018 | Class II | microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME | FHC, Inc. | HAW | |
| Z-2349-2018 | Class II | microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA | FHC, Inc. | HAW | |
| Z-2348-2018 | Class II | microTargeting" Drive System, Product Number 66-ZD-MD-01 | FHC, Inc. | HAW | |
| Z-2347-2018 | Class II | microTargeting" Drive System, Product Number 66-ZD-MD | FHC, Inc. | HAW | |
| Z-2346-2018 | Class II | microTargeting" Drive System, Product Number MT-DS-01 | FHC, Inc. | HAW | |
| Z-2345-2018 | Class II | microTargeting" Drive System, Product Number MT-DS | FHC, Inc. | HAW | |
| Z-0066-2019 | Class II | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS... | Advanced Medical Optics, Inc. | OOE | |
| Z-2282-2018 | Class II | ImagePilot, Model No. D9MA | Konica Minolta, Inc. | LLZ | |
| Z-2281-2018 | Class II | CS-7, Model No. A4C1 | Konica Minolta, Inc. | MQB | |
| Z-2344-2018 | Class II | VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic | Ortho-Clinical Diagnostics, Inc. | DIP | |
| Z-2285-2018 | Class II | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code... | B Braun Medical Inc | FPA | |
| Z-3209-2018 | Class II | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System... | Exactech, Inc. | JWH | |
| Z-2952-2018 | Class II | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of... | Luminex Corporation | PCH | |
| Z-2553-2018 | Class I | AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with... | Jaeger Medical GmbH | BTM | |
| Z-2552-2018 | Class I | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask... | Jaeger Medical GmbH | BTM | |
| Z-2316-2018 | Class II | MX-10 surveillance laser system Product Usage: The expected usage of the product is to... | Wescam Inc | REP | |
| Z-2484-2018 | Class II | Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item... | Stryker Sustainability Solutions | NLQ | |
| Z-2530-2018 | Class III | Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide... | Breas Medical AB | NOU | |
| Z-2058-2018 | Class II | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra... | Carl Zeiss Microscopy, LLC | REM | |
| Z-2108-2018 | Class II | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a... | MedTech SAS | HAW | |
| Z-1955-2018 | Class II | Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet... | Dynarex Corp. | CAN | |
| Z-2113-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump... | Baxter Healthcare Corporation | FRN | |
| Z-2112-2018 | Class II | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump... | Baxter Healthcare Corporation | FRN |