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-0187-2022 | Class II | COVENA PICC Sleeve | Queen Comfort Products LLC | FMQ | |
| Z-0225-2022 | Class I | Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound... | Scrip Inc | ITX | |
| Z-0224-2022 | Class I | Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound... | Scrip Inc | ITX | |
| Z-2500-2021 | Class II | Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2506-2021 | Class II | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is... | In2bones USA, LLC | LXH | |
| Z-2497-2021 | Class II | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2581-2021 | Class II | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model... | Sport Medical Technology Inc | KPT | |
| Z-2580-2021 | Class II | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model... | Sport Medical Technology Inc | KPT | |
| Z-2447-2021 | Class II | MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with... | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-2446-2021 | Class II | syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2445-2021 | Class II | syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for... | Siemens Medical Solutions USA, Inc. | MUJ | |
| Z-2573-2021 | Class II | BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2572-2021 | Class II | BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2571-2021 | Class II | BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2570-2021 | Class II | BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2569-2021 | Class II | BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2568-2021 | Class II | BF-P60 OES Bronchofiberscope, Model No. BF-P60 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2567-2021 | Class II | BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2566-2021 | Class II | BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 | OLYMPUS Corporation of the Americas | EOX | |
| Z-2565-2021 | Class II | BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2564-2021 | Class II | BF-N20 OES Bronchofiberscope, Model No. BF-N20 | OLYMPUS Corporation of the Americas | EOQ | |
| Z-2577-2021 | Class I | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F... | Imperative Care Inc. | NRY | |
| Z-2476-2021 | Class II | The Azurion series (within the limits of the used Operation Room table) are intended for... | Philips North America LLC | OWB | |
| Z-2475-2021 | Class II | The Allura Xper series is intended for use on human patients to perform: "Vascular... | Philips North America LLC | OWB | |
| Z-2474-2021 | Class II | The Allura Xper series is intended for use on human patients to perform: "Vascular... | Philips North America LLC | OWB | |
| Z-2485-2021 | Class II | VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged | Greiner Bio-One North America, Inc. | JKA | |
| Z-2477-2021 | Class II | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct... | Ortho-Clinical Diagnostics, Inc. | QJR | |
| Z-0012-2022 | Class II | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system | GE Healthcare | LLZ | |
| Z-2480-2021 | Class I | EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel... | AMTEC SALES Inc | ITX | |
| Z-0090-2022 | Class I | EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU | Red Medical Supplies | ITX | |
| Z-0089-2022 | Class I | EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU | Red Medical Supplies | ITX | |
| Z-0088-2022 | Class I | EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU | Red Medical Supplies | ITX | |
| Z-2601-2021 | Class II | LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number... | Hill-Rom Inc. | FSA | |
| Z-2473-2021 | Class II | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part... | Cypress Medical Products LLC | GDY | |
| Z-2600-2021 | Class II | LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user... | Hill-Rom Inc. | FSA | |
| Z-2599-2021 | Class II | Stretch Leveller Model Number: 3156200 - The combination of this products allows the user... | Hill-Rom Inc. | FSA | |
| Z-2598-2021 | Class II | FlexoStretch Model Number: 3156057 - The combination of this products allows the user to... | Hill-Rom Inc. | FSA | |
| Z-2597-2021 | Class II | OctoStretch with Stretch Leveller - The combination of this products allows the user to... | Hill-Rom Inc. | FSA | |
| Z-2422-2021 | Class II | Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2421-2021 | Class II | SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems... | Philips North America LLC | LNH | |
| Z-2420-2021 | Class II | Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2419-2021 | Class II | Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2418-2021 | Class II | Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2417-2021 | Class II | Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2416-2021 | Class II | Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2415-2021 | Class II | SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated... | Philips North America LLC | LNH | |
| Z-2414-2021 | Class II | Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2413-2021 | Class II | Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH | |
| Z-2412-2021 | Class II | Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use... | Philips North America LLC | LNH | |
| Z-2411-2021 | Class II | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a... | Philips North America LLC | LNH |