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-1845-2019 | Class II | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc... | Zimmer GmbH | LXH | |
| Z-1381-2019 | Class II | Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part... | Dornier Medtech America, Inc. | GEX | |
| Z-1686-2019 | Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0 | Teleflex Medical | BTR | |
| Z-1685-2019 | Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0 | Teleflex Medical | BTR | |
| Z-1684-2019 | Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0 | Teleflex Medical | BTR | |
| Z-1683-2019 | Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0 | Teleflex Medical | BTR | |
| Z-1682-2019 | Class II | RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0 | Teleflex Medical | BTR | |
| Z-2148-2019 | Class II | Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This... | OLYMPUS Corporation of the Americas | EOQ | |
| Z-1471-2020 | Class II | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 | Verathon Inc. | CCW | |
| Z-1338-2019 | Class II | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound... | Integra Lifesciences Sales LLC | KGN | |
| Z-2349-2019 | Class II | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581... | Abbott Medical | DSQ | |
| Z-2348-2019 | Class II | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left... | Abbott Medical | DSQ | |
| Z-2428-2020 | Class II | Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction... | Providence Medical Technology, Inc. | HWC | |
| Z-1776-2019 | Class II | Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM... | ConforMIS, Inc. | LPH | |
| Z-1775-2019 | Class II | Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM... | ConforMIS, Inc. | LPH | |
| Z-1755-2019 | Class II | Silhouette VR This fully integrated system offers intuitive controls with advanced... | GE Healthcare | KPR | |
| Z-1754-2019 | Class II | Precision 500D The Precision 500D R&F X-ray System is intended to be used as a... | GE Healthcare | JAA | |
| Z-1753-2019 | Class II | Prestilix 1600X Prestilix system is a fully integrated remote controlled digital... | GE Healthcare | KXJ | |
| Z-1752-2019 | Class II | Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a... | GE Healthcare | KPR | |
| Z-1751-2019 | Class II | Prestige II, Prestige SI, Prestige VH Prestige system is a new multi-purpose... | GE Healthcare | JAA | |
| Z-1720-2019 | Class II | Sterile Nail Nipper, Barrel Spring (I68400), Sterile | Centurion Medical Products, LP | PWC | |
| Z-1719-2019 | Class II | Sterile Nail Clipper Concave Edge (67710) | Centurion Medical Products, LP | PWC | |
| Z-1695-2019 | Class II | IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531... | Philips North America LLC | DSI | |
| Z-1694-2019 | Class II | IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All... | Philips North America LLC | DSI | |
| Z-1693-2019 | Class II | IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other... | Philips North America LLC | DSI | |
| Z-1692-2019 | Class II | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and... | Philips North America LLC | DSI | |
| Z-1303-2019 | Class II | T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless... | Zimmer GmbH | HWC | |
| Z-1302-2019 | Class II | T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless... | Zimmer GmbH | HWC | |
| Z-1315-2019 | Class II | Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00... | R82 a/S | INM | |
| Z-1117-2019 | Class I | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF... | Edwards Lifesciences LLC | DXF | |
| Z-1116-2019 | Class I | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only... | Edwards Lifesciences LLC | DXF | |
| Z-1367-2019 | Class II | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0 | CooperSurgical, Inc. | MQH | |
| Z-1243-2019 | Class II | EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm)... | Molnlycke Health Care | KGN | |
| Z-1726-2020 | Class II | Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 | Canon Medical Systems USA, Inc. | JAK | |
| Z-1725-2020 | Class II | Canon Aquilion Precision, Model TSX-304A | Canon Medical Systems USA, Inc. | JAK | |
| Z-1724-2020 | Class II | Canon Aquilion Prime SP, Model TSX-303B | Canon Medical Systems USA, Inc. | JAK | |
| Z-1723-2020 | Class II | Canon Aquilion Prime, Model TSX-303A | Canon Medical Systems USA, Inc. | JAK | |
| Z-1722-2020 | Class II | Canon Aquilion One Vision, Model TSX-301C | Canon Medical Systems USA, Inc. | JAK | |
| Z-1721-2020 | Class II | Canon Aquilion Premium, Model TSX-301B | Canon Medical Systems USA, Inc. | JAK | |
| Z-1720-2020 | Class II | Canon Aquilion One, Model TSX-301A | Canon Medical Systems USA, Inc. | JAK | |
| Z-1719-2020 | Class II | Canon Aquilion Lightning, Model TSX-036A | Canon Medical Systems USA, Inc. | JAK | |
| Z-1240-2019 | Class II | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device... | Philips Medical Systems Nederland B.V. | LNH | |
| Z-1490-2019 | Class II | McKesson Cardiology Hemo | Change Healthcare Israel Ltd. | DQK | |
| Z-1489-2019 | Class II | Horizon Cardiology Hemo | Change Healthcare Israel Ltd. | DQK | |
| Z-1874-2019 | Class I | HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1... | Hamilton Medical AG | CBK | |
| Z-2540-2019 | Class II | Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for... | STRYKER Communications, Inc. | FSY | |
| Z-2539-2019 | Class II | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for... | STRYKER Communications, Inc. | FSY | |
| Z-1698-2019 | Class II | TLS2 Thermal Ligating Shears, Catalog Number 132-131D | Microline Surgical, Inc | GEI | |
| Z-1295-2019 | Class II | Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1286-2019 | Class II | ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus... | Medtronic, Inc. | LZA |