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-1400-2022 | Class I | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made | Haimen Shengbang Laboratory Equipment Co. Ltd. | QMC | |
| Z-1399-2022 | Class I | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1 | Haimen Shengbang Laboratory Equipment Co. Ltd. | QMC | |
| Z-1398-2022 | Class I | HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type | Haimen Shengbang Laboratory Equipment Co. Ltd. | QMC | |
| Z-0329-2025 | Class II | SafeControl handset (a component of the Sentida bed which moves and positions the bed)... | Wissner-Bosserhoff GmbH | LLI | |
| Z-1561-2022 | Class I | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No... | Synapse Biomedical Inc | OIR | |
| Z-1522-2022 | Class I | INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion... | Intera Oncology | LKK | |
| Z-1674-2022 | Class II | Pentacam HR REF 70900. Used to image the anterior segment of the eye. | Oculus Optikgerate GmbH | MXK | |
| Z-1673-2022 | Class II | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of... | Oculus Optikgerate GmbH | MXK | |
| Z-1672-2022 | Class II | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. | Oculus Optikgerate GmbH | MXK | |
| Z-1671-2022 | Class II | The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to... | Boston Scientific Corporation | NIK | |
| Z-1670-2022 | Class II | The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to... | Boston Scientific Corporation | LWS | |
| Z-1643-2022 | Class II | AIM-V Medium REF AV.200/500 | Oxford Immunotec Ltd | OJN | |
| Z-1642-2022 | Class II | T-Cell Xtend REF TTK.610 US | Oxford Immunotec Ltd | OJN | |
| Z-1641-2022 | Class II | T-Spot.tb Ref Tb.300 US | Oxford Immunotec Ltd | OJN | |
| Z-1514-2022 | Class II | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S | OLYMPUS Corporation of the Americas | FEO | |
| Z-1669-2022 | Class II | The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE... | Boston Scientific Corporation | LWS | |
| Z-1742-2022 | Class II | ZAP-X Radiosurgery System | Zap Surgical Systems Inc. | IYE | |
| Z-0114-2023 | Class II | Medicina Reusable Oral syringe 2.5ml Code: OTH25 | Medicina Ltd | KYW | |
| Z-0113-2023 | Class II | Medicina Reusable Oral syringe 5ml Code: OTH05 | Medicina Ltd | KYW | |
| Z-0112-2023 | Class II | Medicina Reusable Oral syringe 1ml Code: OTH01 | Medicina Ltd | KYW | |
| Z-0111-2023 | Class II | Medicina Oral Tip Syringe 2.5ml Code: OT25 | Medicina Ltd | KYW | |
| Z-0110-2023 | Class II | Medicina Oral Tip Syringe 1ml Code: OT01 | Medicina Ltd | KYW | |
| Z-0109-2023 | Class II | Medicina Oral Tip Syringe 0.5ml Code: OT005 | Medicina Ltd | KYW | |
| Z-0108-2023 | Class II | Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 | Medicina Ltd | KYW | |
| Z-0107-2023 | Class II | Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD | Medicina Ltd | KYW | |
| Z-1460-2022 | Class II | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier... | Intuitive Surgical, Inc. | NAY | |
| Z-1459-2022 | Class II | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier... | Intuitive Surgical, Inc. | NAY | |
| Z-1557-2022 | Class II | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | Medtronic, Inc. | KRA | |
| Z-1556-2022 | Class II | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Medtronic, Inc. | KRA | |
| Z-1678-2022 | Class II | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Orthopediatrics Corp | KTT | |
| Z-1677-2022 | Class II | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various... | Biosense Webster Inc | DYB | |
| Z-1551-2022 | Class II | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF | Trinity Sterile, Inc. | OXQ | |
| Z-1550-2022 | Class II | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | Trinity Sterile, Inc. | OXQ | |
| Z-1549-2022 | Class II | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | Trinity Sterile, Inc. | OXQ | |
| Z-1548-2022 | Class II | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Trinity Sterile, Inc. | OXQ | |
| Z-1493-2022 | Class II | MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH... | MEDLINE INDUSTRIES, LP - Northfield | LRJ | |
| Z-1419-2022 | Class II | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the... | Depuy Orthopaedics Inc. | HWT | |
| Z-1387-2022 | Class II | SX-One MicroKnife | SONEX HEALTH, Inc | LXH | |
| Z-1743-2022 | Class III | BIOPHEN UFH Control Plasma | Aniara Diagnostica LLC | GGN | |
| Z-1512-2022 | Class I | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE | HeartWare, Inc. | DSQ | |
| Z-1498-2022 | Class II | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | JIY | |
| Z-1682-2022 | Class II | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag... | Abbott Medical | ONB | |
| Z-1681-2022 | Class II | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/... | Abbott Medical | ONB | |
| Z-1525-2022 | Class I | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | Hamilton Medical AG | CBK | |
| Z-1457-2022 | Class II | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System... | Davol Inc., Sub. C.R. Bard, Inc. | GCJ | |
| Z-1418-2022 | Class II | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis... | Smith & Nephew, Inc. | JWH | |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model 5748519. | GE Healthcare | LNH | |
| Z-1417-2022 | Class II | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. | Baxter Healthcare Corporation | IOQ | |
| Z-1416-2022 | Class II | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. | Baxter Healthcare Corporation | IOQ | |
| Z-1415-2022 | Class II | Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. | Baxter Healthcare Corporation | IOQ |