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-2159-2021 | Class II | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 | Medtronic Neuromodulation | LGW | |
| Z-2281-2021 | Class II | Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm)... | Edwards Lifesciences LLC | DQE | |
| Z-2280-2021 | Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of... | Edwards Lifesciences LLC | DQE | |
| Z-2279-2021 | Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm)... | Edwards Lifesciences LLC | DQE | |
| Z-2278-2021 | Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm)... | Edwards Lifesciences LLC | DQE | |
| Z-2501-2021 | Class II | Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein... | Argon Medical Devices, Inc | DYB | |
| Z-2158-2021 | Class II | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a... | Sunrise Medical, Inc. | INM | |
| Z-2543-2021 | Class II | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular... | Vascutek, Ltd. | DXZ | |
| Z-2542-2021 | Class II | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem... | Vascutek, Ltd. | DSY | |
| Z-2157-2021 | Class II | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a... | Sunrise Medical, Inc. | INM | |
| Z-2227-2021 | Class II | Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model... | Carl Zeiss Meditec Inc | OBO | |
| Z-2165-2021 | Class I | Dose IQ Safety Software used with Spectrum IQ Infusion Pump | Baxter Healthcare Corporation | FRN | |
| Z-2426-2021 | Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-2425-2021 | Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-2424-2021 | Class II | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | MOI | |
| Z-2237-2021 | Class II | Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood... | Advance Dx, Inc. | JKA | |
| Z-2383-2021 | Class II | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW... | Zeltiq Aesthetics Inc | OOK | |
| Z-0244-2022 | Class II | Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the... | Bodycad Laboratories, Inc. | LXH | |
| Z-2443-2021 | Class II | The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a... | HERO HEALTH, Inc. | NXB | |
| Z-2450-2021 | Class II | Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is... | Microbiologics, Inc. | JTO | |
| Z-2329-2021 | Class II | Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 | Howmedica Osteonics Corp | JWH | |
| Z-2348-2021 | Class II | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part... | Depuy Orthopaedics Inc. | JWH | |
| Z-2258-2021 | Class II | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN... | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-2257-2021 | Class II | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC... | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-2256-2021 | Class II | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0... | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-2234-2021 | Class II | Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2233-2021 | Class II | Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2232-2021 | Class II | Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2231-2021 | Class II | Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing... | MEDLINE INDUSTRIES, LP - Northfield | OJH | |
| Z-2255-2021 | Class II | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713; | Siemens Healthcare Diagnostics Inc. | QKP | |
| Z-2172-2021 | Class III | GlideScope Go Monitors | Verathon Inc. | CCW | |
| Z-1406-2022 | Class II | LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. | Aesculap Inc | HXW | |
| Z-1405-2022 | Class II | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | Aesculap Inc | HXW | |
| Z-0816-2022 | Class II | Revolution CT, Revolution CT ES | GE Healthcare | JAK | |
| Z-0815-2022 | Class II | Revolution Apex, Revolution CT with Apex Edition | GE Healthcare | JAK | |
| Z-0242-2022 | Class II | Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex... | GE Healthcare | JAK | |
| Z-2404-2021 | Class II | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2308-2021 | Class II | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation... | FUJIFILM Healthcare Americas Corporation | IYN | |
| Z-2239-2021 | Class II | Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13... | Merit Medical Systems, Inc. | DYB | |
| Z-2238-2021 | Class II | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13... | Merit Medical Systems, Inc. | DYB | |
| Z-2307-2021 | Class II | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work... | CooperSurgical, Inc. | FMZ | |
| Z-2023-2021 | Class II | The system is intended to produce cross-sectional images of the body by computer... | GE Healthcare | JAK | |
| Z-2022-2021 | Class II | The system is intended to produce cross-sectional images of the body by computer... | GE Healthcare | JAK | |
| Z-2294-2021 | Class II | Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System... | OLYMPUS Corporation of the Americas | GEX | |
| Z-2174-2021 | Class II | Kaguya Automated Peritoneal Dialysis System | Baxter Healthcare Corporation | FKX | |
| Z-2173-2021 | Class II | Sharesource Connectivity Platform for Use with the Amia Automated PD System | Baxter Healthcare Corporation | FKX | |
| Z-2021-2021 | Class II | The system is intended to produce cross-sectional images of the body by computer... | GE Healthcare | JAK | |
| Z-2349-2021 | Class II | Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler... | Oakworks Inc | LGX | |
| Z-2251-2021 | Class II | Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis... | Exactech, Inc. | LZO | |
| Z-2250-2021 | Class II | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. | Exactech, Inc. | LZO |