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-0936-2019 | Class II | Sensis Vibe System, Model Number 11007642, with software version VD10B. | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-0837-2019 | Class II | OMNI K1 Broach Handle, Product Code HS-10054 | Omni Life Science, Inc. | LXH | |
| Z-0844-2019 | Class II | Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the... | Ortho-Clinical Diagnostics, Inc. | JIS | |
| Z-0791-2020 | Class II | ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm... | Implant Direct Sybron Manufacturing LLC | NDP | |
| Z-0790-2020 | Class II | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm... | Implant Direct Sybron Manufacturing LLC | NDP | |
| Z-0735-2019 | Class II | Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product... | Zimmer GmbH | FSM | |
| Z-0734-2019 | Class II | Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product... | Zimmer GmbH | FSM | |
| Z-0701-2019 | Class III | IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation... | Boston Scientific Corporation | OAD | |
| Z-0700-2019 | Class III | IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation... | Boston Scientific Corporation | OAD | |
| Z-0699-2019 | Class III | Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation... | Boston Scientific Corporation | OAD | |
| Z-0605-2019 | Class II | Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an... | Howmedica Osteonics Corp | MAX | |
| Z-1072-2019 | Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port... | Abbott Medical | DRS | |
| Z-1071-2019 | Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port... | Abbott Medical | DRS | |
| Z-1070-2019 | Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port... | Abbott Medical | DRS | |
| Z-0786-2019 | Class II | SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation... | Medtronic Perfusion Systems | CAC | |
| Z-0785-2019 | Class II | RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are... | Medtronic Perfusion Systems | CAC | |
| Z-0681-2019 | Class II | Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands... | Medical Action Industries, Inc. 306 | GDY | |
| Z-0379-2019 | Class II | Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a... | AROA Biosurgery Inc. | KGN | |
| Z-0378-2019 | Class II | Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a... | AROA Biosurgery Inc. | KGN | |
| Z-0377-2019 | Class II | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a... | AROA Biosurgery Inc. | KGN | |
| Z-0352-2020 | Class II | ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner... | Abbott Medical | FOZ | |
| Z-0657-2019 | Class II | Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can... | Howmedica Osteonics Corp | LXH | |
| Z-0603-2019 | Class II | HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a... | Philips North America LLC | MKJ | |
| Z-1961-2020 | Class II | da Vinci X Surgical System | Intuitive Surgical, Inc. | NAY | |
| Z-1960-2020 | Class II | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | NAY | |
| Z-2208-2019 | Class II | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a... | Abbott Ireland Diagnostics Division | DBF | |
| Z-0964-2019 | Class II | Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the... | American Contract Systems, Inc. | FYA | |
| Z-0669-2019 | Class II | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 | Abbott Ireland Diagnostics Division | MRG | |
| Z-0668-2019 | Class II | Alinity i Progesterone Reagent Kit, List Number 08P3620 | Abbott Ireland Diagnostics Division | JLS | |
| Z-0667-2019 | Class II | Alinity i Estradiol Reagent Kit, List Number 07P5020 | Abbott Ireland Diagnostics Division | CHP | |
| Z-0666-2019 | Class II | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 | Abbott Ireland Diagnostics Division | DHA | |
| Z-0665-2019 | Class II | Alinity i Free T4 Reagent Kit, List Number 07P7030 | Abbott Ireland Diagnostics Division | CEC | |
| Z-0664-2019 | Class II | Alinity i TSH Reagent Kit, List Number 07P4830 | Abbott Ireland Diagnostics Division | JLW | |
| Z-0709-2019 | Class II | Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage... | Zimmer GmbH | LXT | |
| Z-0708-2019 | Class II | Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The... | Zimmer GmbH | LXT | |
| Z-1350-2019 | Class II | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 | Stryker Medical | FPO | |
| Z-1220-2019 | Class II | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product... | Abbott Medical | MXC | |
| Z-0724-2019 | Class II | Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled... | Arthrex GmbH | MBI | |
| Z-0660-2019 | Class II | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with... | Randox Laboratories, Limited | JIX | |
| Z-0582-2019 | Class II | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product... | HeartWare, Inc. | DSQ | |
| Z-0512-2019 | Class II | Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device... | Abbott Medical | FMG | |
| Z-0663-2020 | Class II | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly | LivaNova USA, Inc. | LYJ | |
| Z-0869-2020 | Class II | Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on... | LivaNova USA, Inc. | LYJ | |
| Z-0868-2020 | Class II | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on... | LivaNova USA, Inc. | LYJ | |
| Z-0346-2020 | Class II | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an... | LivaNova USA, Inc. | LYJ | |
| Z-0794-2019 | Class III | Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW | Ascension Orthopedics, Inc. | HSD | |
| Z-0702-2019 | Class II | Presource Kit Total Joint Pack containing a double-wrapped basin component. Product... | Medtronic, Inc. | LRO | |
| Z-0549-2019 | Class II | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended... | Invacare GmbH | FSA | |
| Z-0547-2020 | Class II | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 | VitalScientific | JJF | |
| Z-1146-2020 | Class II | Revanesse Versa, PN40081 | Prollenium Medical Technologies Inc. | LMH |