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-0120-2023 | Class II | MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0117-2023 | Class II | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW... | Abbott Vascular | NKM | |
| Z-0097-2023 | Class II | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain... | Roche Molecular Systems Inc | NSU | |
| Z-0116-2023 | Class II | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip... | Abbott Vascular | NKM | |
| Z-0002-2023 | Class I | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 | Fresenius Kabi USA, LLC | PHC | |
| Z-0115-2023 | Class II | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip... | Abbott Vascular | NKM | |
| Z-1779-2022 | Class II | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | Salter Labs | CBT | |
| Z-0106-2023 | Class II | CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0169-2023 | Class II | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for... | Advanced Medical Optics, Inc. | OAD | |
| Z-0103-2023 | Class II | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in... | Balt USA, LLC | HCG | |
| Z-0004-2023 | Class II | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a... | Philips North America LLC | MWI | |
| Z-1784-2022 | Class I | Therapy Mask 3100 NC/SP | Respironics, Inc. | BZD | |
| Z-1783-2022 | Class I | Wisp and Wisp Youth Nasal Mask | Respironics, Inc. | BZD | |
| Z-1782-2022 | Class I | DreamWisp Nasal Mask with Over the Nose Cushion | Respironics, Inc. | BZD | |
| Z-1781-2022 | Class I | Philips Respironics DreamWear Full Face Mask | Respironics, Inc. | BZD | |
| Z-1780-2022 | Class I | Philips Respironics Amara View Minimal Contact Full-Face Mask | Respironics, Inc. | BZD | |
| Z-0080-2023 | Class II | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 | LUMINOSTICS, Inc dba CLIP HEALTH | QKP | |
| Z-0079-2023 | Class II | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 | STERIS Corporation | GDZ | |
| Z-1817-2022 | Class III | Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same... | Baxter Healthcare Corporation | DSB | |
| Z-1222-2023 | Class II | Recreo Hair Growth Laser Comb | Omm Imports, Inc. D/B/a Zero Gravity | OAP | |
| Z-0088-2023 | Class II | VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure... | MEDLINE INDUSTRIES, LP - Northfield | OFF | |
| Z-0086-2023 | Class II | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | Advanced Medical Optics, Inc. | HQC | |
| Z-0242-2023 | Class II | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B... | Texas Medical Technology Inc. | FYA | |
| Z-0009-2023 | Class II | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle... | B Braun Medical Inc | FOZ | |
| Z-0370-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA | Full Vision Inc | IOL | |
| Z-0369-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE | Full Vision Inc | IOL | |
| Z-0368-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE | Full Vision Inc | IOL | |
| Z-0367-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929 | Full Vision Inc | IOL | |
| Z-0366-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928 | Full Vision Inc | IOL | |
| Z-0365-2023 | Class II | FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927 | Full Vision Inc | IOL | |
| Z-0364-2023 | Class II | FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926 | Full Vision Inc | IOL | |
| Z-1786-2022 | Class II | Micro-X Rover Mobile X-Ray System, Mxu-Rv19 | Micro-X Ltd. | IZL | |
| Z-0457-2023 | Class II | The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter... | Phonesoap | RHP | |
| Z-0094-2023 | Class II | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System... | Siemens Healthcare Diagnostics Inc. | CFN | |
| Z-0093-2023 | Class II | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens... | Siemens Healthcare Diagnostics Inc. | CFN | |
| Z-0008-2023 | Class II | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Synthes (USA) Products LLC | JDR | |
| Z-1744-2022 | Class II | Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. | Philips North America LLC | MUJ | |
| Z-0096-2023 | Class II | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model... | Intersurgical Ltd. | CAE | |
| Z-0077-2023 | Class I | Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient... | Teleflex Medical | CAH | |
| Z-0076-2023 | Class I | Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with... | Teleflex Medical | CAH | |
| Z-0075-2023 | Class I | Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T... | Teleflex Medical | CAH | |
| Z-0074-2023 | Class I | Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only... | Teleflex Medical | CAH | |
| Z-0073-2023 | Class I | Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only... | Teleflex Medical | CAH | |
| Z-0072-2023 | Class I | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter... | Teleflex Medical | CAH | |
| Z-1821-2022 | Class II | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF... | Ossur Americas | ISW | |
| Z-1851-2022 | Class II | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 | Leica Microsystems, Inc. | FSO | |
| Z-1850-2022 | Class II | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | Leica Microsystems, Inc. | FSO | |
| Z-1849-2022 | Class II | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | Leica Microsystems, Inc. | FSO | |
| Z-1848-2022 | Class II | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | Leica Microsystems, Inc. | FSO | |
| Z-1659-2022 | Class I | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive... | Respironics, Inc. | MNS |