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-1062-2009 | AxSOS T8 Screwdriver, 3.0mm Locking Set. REF 702746. This product is non sterile... | Howmedica Osteonics Corp | HRS | ||
| Z-0908-2009 | Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for... | Hill-Rom Inc. | KCY | ||
| Z-0907-2009 | Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for... | Hill-Rom Inc. | KCY | ||
| Z-0954-2009 | LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a... | EMD Millipore Corporation | GNW | ||
| Z-0953-2009 | LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat... | EMD Millipore Corporation | GNW | ||
| Z-0642-2009 | Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes... | Medtronic, Inc. | FGE | ||
| Z-0619-2009 | BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x... | Becton Dickinson & Co | MEG | ||
| Z-0287-2010 | Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the... | Philips North America LLC | JAK | ||
| Z-0286-2010 | Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes... | Philips North America LLC | JAK | ||
| Z-1195-2009 | Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems... | GE Healthcare | MQB | ||
| Z-0947-2009 | VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim... | Medtronic Xomed, Inc. | ETN | ||
| Z-0961-2009 | PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only... | Smith & Nephew, Inc. | KWS | ||
| Z-0960-2009 | PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY(1)... | Smith & Nephew, Inc. | KWS | ||
| Z-1004-2009 | Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each... | Smith & Nephew, Inc. | LPH | ||
| Z-0928-2009 | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0884-2009 | Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per... | Howmedica Osteonics Corp | LZO | ||
| Z-0861-2009 | Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions... | Varian Medical Systems, Inc. | IYE | ||
| Z-0621-2009 | Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy... | Boston Scientific Corporation | LOX | ||
| Z-0034-2011 | The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips... | Philips North America LLC | DSI | ||
| Z-0989-2009 | Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin... | Abbott Medical | LZG | ||
| Z-0988-2009 | Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory... | Abbott Medical | LZG | ||
| Z-0970-2009 | GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare... | GE Healthcare | LLZ | ||
| Z-0931-2009 | Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number... | Synthes GmbH | MAX | ||
| Z-0618-2009 | Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone... | ConvaTec Limited | KNT | ||
| Z-1400-2009 | Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201... | Remel Inc | GTQ | ||
| Z-0650-2009 | Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport... | Stryker Medical | FPP | ||
| Z-0649-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport... | Stryker Medical | FPP | ||
| Z-0616-2009 | Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free... | Medtronic, Inc. | FQM | ||
| Z-0615-2009 | Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free... | Medtronic, Inc. | FQM | ||
| Z-0648-2009 | Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. | Stryker Medical | FPP | ||
| Z-0862-2009 | Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile... | Miltex, Inc. | GES | ||
| Z-1064-2009 | CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a... | Abbott Medical | GKZ | ||
| Z-2312-2010 | Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK... | Physio Control, Inc. | LDD | ||
| Z-2311-2010 | External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and... | Physio Control, Inc. | LDD | ||
| Z-1397-2009 | Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions... | GE Healthcare | JQP | ||
| Z-1009-2009 | Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche... | Roche Diagnostics GmbH | JJE | ||
| Z-0158-2010 | Neos Vanadium Excavator Part Number 591/5 SCHE | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0157-2010 | Neos Vanadium Excavator Part Number 591/3 SCHE | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0156-2010 | Neos Vanadium Excavator Part Number 591/0 SCHE | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0155-2010 | Neos Vanadium Excavator Part Number 591/0-6 | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0154-2010 | Neos Vanadium Excavator Part Number 591/4 | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0153-2010 | Neos Vanadium Excavator Part Number 591/2 | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0152-2010 | Neos Vanadium Excavator Part Number 591/1 | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0151-2010 | Neos Vanadium Excavator Part Number 591/0 | Sybron Dental Specialties, Inc. | EKC | ||
| Z-0629-2009 | Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP)... | Accuray Incorporated | IYE | ||
| Z-1899-2009 | Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with... | STRYKER Communications, Inc. | FQO | ||
| Z-0647-2009 | CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0902-2009 | Secur-Fit ARC/HA Collar Stem These devices are modular components of a total hip... | Howmedica Osteonics Corp | MEH | ||
| Z-0901-2009 | Reunion HA Fracture Stem These devices are modular components of a total hip system... | Howmedica Osteonics Corp | HSD | ||
| Z-0900-2009 | Japanese Omnifit Eon 127 NK These devices are modular components of a total hip... | Howmedica Osteonics Corp | JDI |