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-2365-2023 | Class II | Medtronic InterStim Ground Pad REF 041826 | Medtronic Neuromodulation | EZW | |
| Z-2289-2023 | Class II | TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only | Advanced Medical Optics, Inc. | HQL | |
| Z-0100-2024 | Class II | Access Thyroglobulin Calibrators | Siemens Healthcare Diagnostics Inc. | MSW | |
| Z-2288-2023 | Class II | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Advanced Medical Optics, Inc. | POE | |
| Z-2356-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2355-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2354-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2353-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2352-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2351-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2350-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2349-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2348-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2347-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2346-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2345-2023 | Class II | LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with... | Waldemar Link GmbH & Co. KG | LZO | |
| Z-2366-2023 | Class II | Total Hip Kit, REF DYNJ903275S; surgical convenience kit | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2485-2023 | Class II | Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional... | Philips Medical Systems Nederland B.V. | OWB | |
| Z-2517-2023 | Class II | 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50... | Philips North America LLC | ITX | |
| Z-2465-2023 | Class II | LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray... | Cardiac Assist, Inc | KFM | |
| Z-2281-2023 | Class I | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number... | Abiomed, Inc. | PYX | |
| Z-0982-2025 | Class II | stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone... | Stryker Corp. | HBE | |
| Z-0981-2025 | Class II | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during... | Stryker Corp. | HBE | |
| Z-0980-2025 | Class II | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut... | Stryker Corp. | HBE | |
| Z-2411-2023 | Class II | Alcon Custom Pak | Alcon Laboratories | HQC | |
| Z-2410-2023 | Class II | Phaco Standalone Tips | Alcon Laboratories | HQC | |
| Z-2409-2023 | Class II | Legion FMS Pak | Alcon Laboratories | HQC | |
| Z-2408-2023 | Class II | Infinity FMS Pak | Alcon Laboratories | HQC | |
| Z-2407-2023 | Class II | Centurion FMS Pak | Alcon Laboratories | HQC | |
| Z-2406-2023 | Class II | Constellation Procedure Pak | Alcon Laboratories | HQC | |
| Z-2412-2023 | Class II | Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection... | Medtronic Neurosurgery | JXG | |
| Z-2391-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2390-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... | Medtronic, Inc. | NIE | |
| Z-2389-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2388-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions... | Medtronic, Inc. | NIE | |
| Z-2387-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2386-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... | Medtronic, Inc. | NIE | |
| Z-2385-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2384-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... | Medtronic, Inc. | NIE | |
| Z-2383-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2382-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2381-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight... | Medtronic, Inc. | NIE | |
| Z-2380-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF... | Medtronic, Inc. | NIE | |
| Z-2379-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight... | Medtronic, Inc. | NIE | |
| Z-2378-2023 | Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF... | Medtronic, Inc. | NIE | |
| Z-2377-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight... | Medtronic, Inc. | NIE | |
| Z-2376-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight... | Medtronic, Inc. | NIE | |
| Z-2375-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2374-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved... | Medtronic, Inc. | NIE | |
| Z-2373-2023 | Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved... | Medtronic, Inc. | NIE |