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-1853-2014 | Class II | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by... | Nidek Incorporated | HKN | |
| Z-2002-2014 | Class II | 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the... | 3M Company | FRC | |
| Z-1120-2015 | Class II | Philips Medical System Allura Xper X-Ray Angiographic | Philips North America LLC | IZI | |
| Z-0976-2015 | Class II | Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose... | Becton Dickinson & Co | JSG | |
| Z-0975-2015 | Class II | CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched... | Becton Dickinson & Co | JSG | |
| Z-0974-2015 | Class II | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy... | Becton Dickinson & Co | JSI | |
| Z-2027-2014 | Class II | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet... | Abbott Medical | FRN | |
| Z-2081-2014 | Class II | AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in... | AGFA Healthcare Corp. | IZL | |
| Z-1852-2014 | Class II | Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to... | GE Healthcare | MHX | |
| Z-1977-2014 | Class II | BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In... | Becton, Dickinson and Company, BD Biosciences | OYE | |
| Z-2569-2014 | Class II | Artis zee and Artis zeego systems. x-ray, angiographic system | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-2587-2014 | Class II | AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-2070-2014 | Class II | Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead... | Excelsior Medical LLC | LHI | |
| Z-2698-2014 | Class II | UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32... | Argon Medical Devices, Inc | MSD | |
| Z-2697-2014 | Class II | UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32... | Argon Medical Devices, Inc | MSD | |
| Z-2696-2014 | Class II | UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm)... | Argon Medical Devices, Inc | MSD | |
| Z-2017-2014 | Class II | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2016-2014 | Class II | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. | Teleflex Medical | BTT | |
| Z-2015-2014 | Class II | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor. | Teleflex Medical | BTT | |
| Z-2014-2014 | Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2013-2014 | Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2012-2014 | Class II | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2011-2014 | Class II | Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2010-2014 | Class II | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. | Teleflex Medical | BTT | |
| Z-2009-2014 | Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2008-2014 | Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2007-2014 | Class II | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2006-2014 | Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier... | Teleflex Medical | BTT | |
| Z-2005-2014 | Class II | Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2004-2014 | Class II | Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2003-2014 | Class II | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas... | Teleflex Medical | BTT | |
| Z-2069-2014 | Class II | Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional... | Axcentria Pharmaceuticals, LLC | EJK | |
| Z-0142-2015 | Class II | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23... | DMS Holdings, Inc. | ITJ | |
| Z-0161-2018 | Class II | ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the... | Zimmer GmbH | HAW | |
| Z-2125-2014 | Class II | DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal... | DeRoyal Industries, Inc. | LRO | |
| Z-2124-2014 | Class II | DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal... | DeRoyal Industries, Inc. | LRO | |
| Z-1989-2014 | Class II | GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d... | GE Healthcare | KPR | |
| Z-1988-2014 | Class II | GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in... | GE Healthcare | KPR | |
| Z-1943-2014 | Class II | Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee... | Blue Belt Technologies MN | HSX | |
| Z-1942-2014 | Class II | Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee... | Blue Belt Technologies MN | HSX | |
| Z-2122-2014 | Class II | InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151... | Stryker Medical | FNL | |
| Z-1809-2014 | Class II | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the... | Medtronic, Inc. | CBK | |
| Z-2038-2014 | Class II | PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use... | Pall Corporation | CAH | |
| Z-2066-2014 | Class II | ACL TOP 300 CTS, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2065-2014 | Class II | ACL TOP 700 CTS, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2064-2014 | Class II | ACL TOP 500 CTS, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2063-2014 | Class II | ACL TOP 700 LAS, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2062-2014 | Class II | ACL TOP CTS, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2061-2014 | Class II | ACL TOP 700, automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP | |
| Z-2060-2014 | Class II | ACL TOP (Base), automated coagulation laboratory instrument. | Instrumentation Laboratory Co. | GKP |