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-0649-2022 | Class II | Veradius Unity, Model #718132 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-0648-2022 | Class II | Zenition 70, Model #718133 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-0647-2022 | Class II | Zenition 50, Model #718096 | Philips Medical Systems Nederland B.V. | OWB | |
| Z-0661-2022 | Class II | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus... | Natus Medical Incorporated | OMB | |
| Z-0532-2022 | Class II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20... | LivaNova USA, Inc. | LYJ | |
| Z-0558-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test... | Celltrion USA Inc | QKP | |
| Z-0440-2022 | Class II | Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | JZG | |
| Z-0552-2022 | Class II | Premier Rotaclone, Rx only | MEDLINE INDUSTRIES, LP - Northfield | LIQ | |
| Z-0656-2022 | Class II | Michels Transport Medium, 20ML Prefilled Cont | MEDLINE INDUSTRIES, LP - Northfield | NNI | |
| Z-0554-2022 | Class II | HARDY DIAGNOSTICS CatScreen, 25dsk/vial | MEDLINE INDUSTRIES, LP - Northfield | JTO | |
| Z-0403-2022 | Class II | Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 | Maquet Cardiovascular LLC | MAL | |
| Z-0513-2022 | Class II | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | Straumann USA, LLC | DZE | |
| Z-0512-2022 | Class II | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item... | Straumann USA, LLC | DZE | |
| Z-0404-2022 | Class II | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 | MEDLINE INDUSTRIES, LP - Northfield | DIF | |
| Z-0469-2022 | Class II | Regard, T AND A - Rogers, sterilized convenience kits | ROi CPS LLC | OGR | |
| Z-0386-2022 | Class II | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Activbody | LBB | |
| Z-0385-2022 | Class II | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5... | Activbody | LBB | |
| Z-0466-2022 | Class II | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Ion Beam Applications S.A. | LHN | |
| Z-0509-2022 | Class II | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | Philips North America LLC | IMD | |
| Z-0508-2022 | Class II | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | Philips North America LLC | IMD | |
| Z-0507-2022 | Class II | Heel Snuggler, Reference # 989805603411 99047 | Philips North America LLC | MPO | |
| Z-0506-2022 | Class II | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | Philips North America LLC | IMD | |
| Z-0505-2022 | Class II | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | Philips North America LLC | IMD | |
| Z-0725-2022 | Class II | Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird... | Philips North America LLC | OWB | |
| Z-0724-2022 | Class II | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray... | Philips North America LLC | OWB | |
| Z-0470-2022 | Class II | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000... | Reflexion Medical, Inc. | IYE | |
| Z-0459-2022 | Class II | Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and... | Howmedica Osteonics Corp | FSM | |
| Z-0456-2022 | Class II | DBB-06 Hemodialysis Delivery System | Nikkiso Co., Ltd. - Shizuoka Plant | KDI | |
| Z-0499-2022 | Class II | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material #... | Siemens Medical Solutions USA, Inc. | DQK | |
| Z-0496-2022 | Class II | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | Gentherm Medical, LLC | ILO | |
| Z-0458-2022 | Class II | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. | Uromedica Inc. | EZY | |
| Z-0503-2022 | Class II | VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack | Ortho-Clinical Diagnostics, Inc. | PPM | |
| Z-0847-2022 | Class II | BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile... | Halyard Health | BSY | |
| Z-0846-2022 | Class II | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile... | Halyard Health | BSY | |
| Z-0845-2022 | Class II | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for... | Halyard Health | BSY | |
| Z-0394-2022 | Class I | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter... | Cardiovascular Systems Incorporated | NTE | |
| Z-1746-2022 | Class II | QIAcube Connect MDx, Model No. 9003070 | Qiagen | JJH | |
| Z-1574-2023 | Class II | Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit... | Medtronic Sofamor Danek USA Inc | LXH | |
| Z-0475-2022 | Class II | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0474-2022 | Class II | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0473-2022 | Class II | SOMATOM Definition AS-Computed tomography system Model 8098027 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0472-2022 | Class II | SOMATOM Confidence -Computed tomography systems Model 10590100 | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0467-2022 | Class III | Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little... | Ki Mobility | INM | |
| Z-0416-2022 | Class II | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular... | Philips North America LLC | OWB | |
| Z-0464-2022 | Class II | Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding... | Medtronic, Inc. | QAN | |
| Z-0457-2022 | Class II | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | DiaSorin Molecular LLC | OOI | |
| Z-0449-2022 | Class II | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical... | Siemens Healthcare Diagnostics Inc. | JGS | |
| Z-0553-2022 | Class II | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 | Luminex Corporation | OOI | |
| Z-0497-2022 | Class II | Senior Living Arial Emergency and Nurse Call Systems | Securitas Healthcare LLC | IQA | |
| Z-0453-2022 | Class II | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | Medshape, Inc. | HWC |