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-1156-2020 | Class II | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog... | Medicrea International | MAX | |
| Z-1629-2020 | Class II | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | Carl Zeiss Microscopy, LLC | RIB | |
| Z-0411-2020 | Class II | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly... | Boston Scientific Corporation | GEI | |
| Z-0361-2020 | Class II | 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument... | Exactech, Inc. | NDL | |
| Z-0270-2020 | Class II | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic... | Orthopediatrics Canada ULC | LXH | |
| Z-1449-2022 | Class II | Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50... | Aesculap Inc | PUI | |
| Z-1579-2020 | Class II | PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended... | Bard Peripheral Vascular Inc | LJT | |
| Z-1578-2020 | Class II | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen... | Bard Peripheral Vascular Inc | LJT | |
| Z-1577-2020 | Class II | BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen... | Bard Peripheral Vascular Inc | LJT | |
| Z-1576-2020 | Class II | BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous... | Bard Peripheral Vascular Inc | LJT | |
| Z-1575-2020 | Class II | BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous... | Bard Peripheral Vascular Inc | LJT | |
| Z-1574-2020 | Class II | 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2... | Bard Peripheral Vascular Inc | LJT | |
| Z-1573-2020 | Class II | 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000... | Bard Peripheral Vascular Inc | LJT | |
| Z-1572-2020 | Class II | 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen... | Bard Peripheral Vascular Inc | LJT | |
| Z-1571-2020 | Class II | 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous... | Bard Peripheral Vascular Inc | LJT | |
| Z-1570-2020 | Class II | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous... | Bard Peripheral Vascular Inc | LJT | |
| Z-1510-2020 | Class II | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used... | Arthrex GmbH | HWC | |
| Z-0238-2020 | Class II | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing... | Datascope Corp. | MWI | |
| Z-0237-2020 | Class II | Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing... | Datascope Corp. | MWI | |
| Z-0236-2020 | Class II | Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | Datascope Corp. | MWI | |
| Z-0235-2020 | Class II | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... | Datascope Corp. | MWI | |
| Z-0354-2020 | Class II | EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) | Monarch Medical Technologies | NDC | |
| Z-0752-2020 | Class II | Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE... | Roche Diabetes Care, Inc. | NBW | |
| Z-0751-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN... | Roche Diabetes Care, Inc. | NBW | |
| Z-0750-2020 | Class II | Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN... | Roche Diabetes Care, Inc. | NBW | |
| Z-0749-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY... | Roche Diabetes Care, Inc. | NBW | |
| Z-0748-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT... | Roche Diabetes Care, Inc. | NBW | |
| Z-0747-2020 | Class II | Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT... | Roche Diabetes Care, Inc. | NBW | |
| Z-0870-2020 | Class II | EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband... | Energetiq Technology Inc | REK | |
| Z-0760-2020 | Class I | Airway Gas Option N-CAiO | GE Healthcare | CCK | |
| Z-0759-2020 | Class I | CARESCAPE Respiratory Module E-sCAiOVE | GE Healthcare | CCK | |
| Z-0758-2020 | Class I | CARESCAPE Respiratory Module E-sCAiOE | GE Healthcare | CCK | |
| Z-0757-2020 | Class I | CARESCAPE Respiratory Module E-sCAiOV | GE Healthcare | CCK | |
| Z-0756-2020 | Class I | CARESCAPE Respiratory Module E-sCAiO | GE Healthcare | CCK | |
| Z-0755-2020 | Class I | CARESCAPE Respiratory Module E-sCOVX | GE Healthcare | CCK | |
| Z-0754-2020 | Class I | CARESCAPE Respiratory Module E-sCO | GE Healthcare | CCK | |
| Z-1266-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | Theralase Technologies Inc. | NHN | |
| Z-1326-2020 | Class III | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary... | Theralase Technologies Inc. | NHN | |
| Z-1353-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | Theralase Technologies Inc. | NHN | |
| Z-1354-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | Theralase Technologies Inc. | NHN | |
| Z-1348-2020 | Class III | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Theralase Technologies Inc. | NHN | |
| Z-0607-2020 | Class III | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the... | Theralase Technologies Inc. | NHN | |
| Z-0606-2020 | Class III | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. | Theralase Technologies Inc. | NHN | |
| Z-0188-2020 | Class II | Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer... | Life Technologies Holdings Pte Ltd. | PFF | |
| Z-0187-2020 | Class II | Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software... | Life Technologies Holdings Pte Ltd. | PFF | |
| Z-0186-2020 | Class II | Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software... | Life Technologies Holdings Pte Ltd. | PFF | |
| Z-0185-2020 | Class II | Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software... | Life Technologies Holdings Pte Ltd. | PFF | |
| Z-1383-2022 | Class II | AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical... | Aesculap Inc | HXK | |
| Z-0176-2020 | Class II | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER... | Brainlab, Inc. | LMA | |
| Z-0542-2020 | Class II | myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart... | Endotronix, Inc. | OUG |