Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2024 | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Ser... | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... | Class II | GE OEC Medical Systems, Inc |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V;... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEM... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC... | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential o... | Class II | GE OEC Medical Systems, Inc |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PAC... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ6... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 20, 2024 | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | The following four issues are included: 1. Certain Channel Settings may result in an Access Poi... | Class II | Philips North America Llc |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 19, 2024 | VACUETTE SAFELINK, REF: 450210 | The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber slee... | Class II | Greiner Bio-One GmbH |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 19, 2024 | Duravent Silicone Ventilation Tube. Model Number: 240075. | Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1... | Class II | Olympus Corporation of the Americas |
| Nov 19, 2024 | SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (... | Incomplete or partial pouch seals, which may result in a breach in the sterility. | Class II | Med Michigan Holding Llc |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Pr... | There is a potential safety risk caused by physical disassociation of the back section from the b... | Class II | Elucent Medical Inc |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; trac... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... | Class II | GE Medical Systems, LLC |
| Nov 18, 2024 | Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... | Class II | GE Medical Systems, LLC |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tra... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For ... | Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The ... | Class II | Beckman Coulter, Inc. |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder n... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-0... | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... | Class II | GE Medical Systems, LLC |
| Nov 18, 2024 | Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... | Class II | GE Medical Systems, LLC |
| Nov 18, 2024 | Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV | Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less a... | Class II | GE Medical Systems, LLC |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Re... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 16, 2024 | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... | Class II | Philips North America Llc |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.10.0 and 3.10.1. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Nu... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis CII Safe ES, REF: 1116-00 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 13, 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 | The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler p... | Class II | Beckman Coulter, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.