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-0978-2019 | Class I | e700 Automatic Transport Ventilator, Model Number 01EVE700 | O-Two Medical Technologies, Inc. | BTL | |
| Z-0977-2019 | Class I | e600 Automatic Transport Ventilator, Model Number 01EVE600 | O-Two Medical Technologies, Inc. | BTL | |
| Z-0976-2019 | Class I | e500 Automatic Transport Ventilator, Model Number 01EVE500 | O-Two Medical Technologies, Inc. | BTL | |
| Z-1733-2019 | Class II | Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only... | Abbott Medical | FMI | |
| Z-1732-2019 | Class II | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a... | Abbott Medical | BTO | |
| Z-1059-2019 | Class II | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion... | Fenwal Inc | CAC | |
| Z-0795-2020 | Class II | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on... | Riverpoint Medical, LLC | IWJ | |
| Z-0360-2020 | Class II | Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage... | Canon Medical Systems USA, Inc. | MQB | |
| Z-0986-2019 | Class I | Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency... | Maquet Cardiovascular Us Sales, LLC | DTQ | |
| Z-2006-2019 | Class II | Terumo Needle, 30G x 1/2", Product Code NN3013R | Terumo Medical Corp. | FMI | |
| Z-2005-2019 | Class II | Terumo Needle, 23G x 1", Product Code NN2325R | Terumo Medical Corp. | FMI | |
| Z-2004-2019 | Class II | Terumo Needle, 18G x 1", Product Code NN1825R | Terumo Medical Corp. | FMI | |
| Z-2003-2019 | Class II | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 | Terumo Medical Corp. | FMI | |
| Z-2002-2019 | Class II | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | Terumo Medical Corp. | FMI | |
| Z-2001-2019 | Class II | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | Terumo Medical Corp. | FMI | |
| Z-2000-2019 | Class II | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | Terumo Medical Corp. | FMI | |
| Z-1999-2019 | Class II | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | Terumo Medical Corp. | FMI | |
| Z-1998-2019 | Class II | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | Terumo Medical Corp. | FMI | |
| Z-0985-2019 | Class II | Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0984-2019 | Class II | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid... | Siemens Medical Solutions USA, Inc. | JAA | |
| Z-0965-2019 | Class II | Monaco Radiation Treatment Planning (RTP) System | Elekta Limited | MUJ | |
| Z-0975-2019 | Class II | Omega Systems These devices are intended to be used in the environment where patient... | Draeger Medical Systems, Inc. | MHX | |
| Z-0974-2019 | Class II | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa)... | Draeger Medical Systems, Inc. | MHX | |
| Z-1198-2019 | Class III | Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter... | Cordis US Corp. | DQY | |
| Z-1107-2019 | Class III | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is... | Randox Laboratories, Limited | JJY | |
| Z-1106-2019 | Class III | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This... | Randox Laboratories, Limited | JJY | |
| Z-1105-2019 | Class III | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This... | Randox Laboratories, Limited | JJY | |
| Z-1085-2019 | Class II | Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. | Advanced Bionics LLC | MCM | |
| Z-1084-2019 | Class II | Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model... | Advanced Bionics LLC | MCM | |
| Z-1083-2019 | Class II | Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model... | Advanced Bionics LLC | MCM | |
| Z-1294-2019 | Class II | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry... | Medica Corp. | CHI | |
| Z-1050-2019 | Class II | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a... | LW Scientific, Inc. | JQC | |
| Z-1049-2019 | Class II | LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a... | LW Scientific, Inc. | JQC | |
| Z-1048-2019 | Class II | LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a... | LW Scientific, Inc. | JQC | |
| Z-0546-2020 | Class III | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Spineart SA | MAX | |
| Z-1354-2019 | Class II | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a... | Abbott Ireland Diagnostics Division | CHP | |
| Z-1353-2019 | Class II | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is... | Abbott Ireland Diagnostics Division | CHP | |
| Z-0611-2020 | Class II | EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP... | Encore Medical, LP | LXH | |
| Z-1027-2019 | Class II | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product... | Cp Medical | GAL | |
| Z-1011-2019 | Class II | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is... | United States Endoscopy Group, Inc. | PKL | |
| Z-1368-2019 | Class II | Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data... | Roche Diagnostics GmbH | JQP | |
| Z-1352-2019 | Class II | Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos... | Etac A/S | FSA | |
| Z-1351-2019 | Class II | Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos... | Etac A/S | FSA | |
| Z-2008-2019 | Class II | 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 | Becton Dickinson & Co | FMI | |
| Z-2007-2019 | Class II | 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573 | Becton Dickinson & Co | FMF | |
| Z-1006-2019 | Class II | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM... | Zimmer Trabecular Metal Technology, Inc. | JWH | |
| Z-1005-2019 | Class II | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM... | Zimmer Trabecular Metal Technology, Inc. | JWH | |
| Z-0979-2019 | Class I | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For... | Cook Incorporated | DRC | |
| Z-0863-2019 | Class I | LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15... | Physio Control, Inc. | MKJ | |
| Z-0862-2019 | Class I | LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator... | Physio Control, Inc. | MKJ |