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-1144-2017 | Class II | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by... | Physio Control, Inc. | MKJ | |
| Z-1143-2017 | Class II | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in... | Physio Control, Inc. | MKJ | |
| Z-2057-2017 | Class II | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body... | Med-Hot Thermal Imaging, Inc. | LHQ | |
| Z-0205-2018 | Class II | Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection... | Won Industry Co. | IRP | |
| Z-0204-2018 | Class II | Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for... | Won Industry Co. | IRP | |
| Z-1853-2017 | Class II | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | Boston Scientific Corporation | FPA | |
| Z-1151-2017 | Class II | InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an... | Vertebral Technologies, Inc. | LXH | |
| Z-1519-2017 | Class II | Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and... | Teleflex Medical | BTQ | |
| Z-1257-2017 | Class I | The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a... | Physio Control, Inc. | MKJ | |
| Z-1250-2017 | Class II | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product... | Vascular Solutions LLC | DQO | |
| Z-1178-2017 | Class II | Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. | Boston Scientific Corporation | LWS | |
| Z-1123-2017 | Class I | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and... | Physio Control, Inc. | MKJ | |
| Z-1138-2017 | Class II | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all... | Eastman Kodak Company | IZL | |
| Z-2882-2018 | Class II | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging... | Wenzel Spine | LLZ | |
| Z-1461-2017 | Class II | L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International... | Kiscomedica S.A. | MAX | |
| Z-1381-2017 | Class II | Vein Tray, part number AMS6312 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1380-2017 | Class II | Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1379-2017 | Class II | Upper Torso Tray, part number PSS1554(B | Windstone Medical Packaging, Inc. | FSY | |
| Z-1378-2017 | Class II | Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1377-2017 | Class II | Universal Pack, part number AMS2036 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1376-2017 | Class II | Transvaginal Pack, part number CMP1767 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1375-2017 | Class II | Total Knee Pack (15710), part number AMS6563 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1374-2017 | Class II | Total Joint Pack, part number 006358-6 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1373-2017 | Class II | Total Hip Pack, part number PSS2956 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1372-2017 | Class II | Surgical Pack, part number PSS3540(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1371-2017 | Class II | Stem Pack, part number AMS5166 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1370-2017 | Class II | Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1369-2017 | Class II | Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1368-2017 | Class II | Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1367-2017 | Class II | Set-Up Pack, part number PSS1305(C | Windstone Medical Packaging, Inc. | FSY | |
| Z-1366-2017 | Class II | Set Up Pack, part number PSS3574(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1365-2017 | Class II | Robotic Pack, part number AMS4389 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1364-2017 | Class II | Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1363-2017 | Class II | Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1362-2017 | Class II | Plastic Surgery Pack, part number AMS5685 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1361-2017 | Class II | Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1360-2017 | Class II | Plastic Kit, part number CMP1084(C | Windstone Medical Packaging, Inc. | FSY | |
| Z-1359-2017 | Class II | Plastic General Pack, part number AMS4215 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1358-2017 | Class II | Peri GYN, part number PSS2193(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1357-2017 | Class II | Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1356-2017 | Class II | Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1355-2017 | Class II | Ortho Pack, part number PSS3466(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1354-2017 | Class II | Ortho Minor Pack, part number AMS3710(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1353-2017 | Class II | Orbitofacial Pack, part number AMS5850(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1352-2017 | Class II | Opgrande Hand Pack, part number AMS4767 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1351-2017 | Class II | Open Procedure Pack II, part number RMS1740(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1350-2017 | Class II | Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open... | Windstone Medical Packaging, Inc. | FSY | |
| Z-1349-2017 | Class II | Ocular Plastic Pack, part number AMS3868(A | Windstone Medical Packaging, Inc. | FSY | |
| Z-1348-2017 | Class II | Newport Coast Basic Pack, part number 007484-1 | Windstone Medical Packaging, Inc. | FSY | |
| Z-1347-2017 | Class II | Nasal Pack, part number PSS2186 | Windstone Medical Packaging, Inc. | FSY |