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-0569-2020 | Class II | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | Wright Medical Technology Inc | HRS | |
| Z-0568-2020 | Class II | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 | Wright Medical Technology Inc | GFF | |
| Z-0567-2020 | Class II | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S | Wright Medical Technology Inc | HWC | |
| Z-0566-2020 | Class II | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 | Wright Medical Technology Inc | HSB | |
| Z-0565-2020 | Class II | INBONE STEM, TIBIAL, TOP, Part Number 200011901 | Wright Medical Technology Inc | HSN | |
| Z-0564-2020 | Class II | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 | Wright Medical Technology Inc | MBP | |
| Z-0563-2020 | Class II | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538 | Wright Medical Technology Inc | HWC | |
| Z-0562-2020 | Class II | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | Wright Medical Technology Inc | KWD | |
| Z-0739-2017 | Class II | Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled | Stryker Medical | FPO | |
| Z-1033-2017 | Class II | PREMIER EHEC and PREMIER EHEC Bulk. | Meridian Bioscience Inc | GNA | |
| Z-0679-2017 | Class II | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone... | Teleflex Medical | KNW | |
| Z-0678-2017 | Class II | OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone... | Teleflex Medical | KNW | |
| Z-0677-2017 | Class II | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl... | Teleflex Medical | KNW | |
| Z-0676-2017 | Class II | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow... | Teleflex Medical | KNW | |
| Z-0675-2017 | Class II | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for... | Teleflex Medical | KNW | |
| Z-0703-2017 | Class II | LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in... | Depuy Orthopaedics Inc. | NJL | |
| Z-0529-2019 | Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme... | Helena Laboratories, Corp. | JJX | |
| Z-1032-2017 | Class II | Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 | Exactech, Inc. | LZO | |
| Z-1031-2017 | Class II | AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm... | Exactech, Inc. | LPH | |
| Z-1030-2017 | Class II | Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented... | Exactech, Inc. | JDI | |
| Z-0740-2017 | Class II | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by... | Becton Dickinson & Co | OFT | |
| Z-0927-2017 | Class II | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of... | Medrad, Inc. | FRN | |
| Z-1225-2017 | Class II | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. | Tosoh Bioscience Inc | JCM | |
| Z-0713-2017 | Class II | PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product... | DeRoyal Industries, Inc. | IQI | |
| Z-0712-2017 | Class II | TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product... | DeRoyal Industries, Inc. | IQI | |
| Z-0654-2017 | Class II | The Hemotherm 400CE 115v, containing power board p/n 39945 | Gentherm Medical, LLC | DWS | |
| Z-0667-2017 | Class II | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model... | Siemens Medical Solutions USA, Inc. | IYN | |
| Z-0702-2017 | Class II | MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue... | Thayer Intellectual Property, Inc. | LXH | |
| Z-0955-2017 | Class II | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a... | Voco GmbH | KLE | |
| Z-0660-2017 | Class II | Monaco RTP System; Used to make treatment plans for patients with prescriptions for... | Elekta Limited | MUJ | |
| Z-0754-2017 | Class II | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | OLYMPUS Corporation of the Americas | FAS | |
| Z-0674-2017 | Class II | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | Terumo BCT, Ltd | MUU | |
| Z-0755-2017 | Class II | GE Healthcare, Avance, Avance CS2, Amingo. | GE Healthcare | BSZ | |
| Z-0608-2017 | Class II | SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0607-2017 | Class II | SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0606-2017 | Class II | SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0681-2017 | Class II | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Synthes (USA) Products LLC | HWE | |
| Z-0603-2017 | Class II | AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0602-2017 | Class II | Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0601-2017 | Class II | Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0767-2017 | Class II | IVEA 500A Intended for Med-Surg patient care. | Firefly Medical, Inc. | FOX | |
| Z-1520-2017 | Class II | Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and... | CareFusion 303, Inc | FRN | |
| Z-1439-2017 | Class II | CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, | Abbott Medical | MEA | |
| Z-0991-2017 | Class II | ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS... | ConforMIS, Inc. | JWH | |
| Z-0888-2017 | Class II | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x... | Owens & Minor Distribution, Inc. | ILI | |
| Z-0663-2017 | Class II | Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena... | Spectranetics Corp. | MJN | |
| Z-0662-2017 | Class II | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016... | Spectranetics Corp. | LPC | |
| Z-0661-2017 | Class II | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152... | Spectranetics Corp. | MCW | |
| Z-0656-2017 | Class II | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are... | Synthes (USA) Products LLC | HTO | |
| Z-0716-2017 | Class II | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval... | LivaNova USA, Inc. | LWR |