Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3... | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: N... | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: N... | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 24, 2024 | Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; | Lack of 510(k) clearance. | Class II | Adept Medical Ltd |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... | Class II | Cook Biotech, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... | Class II | Cook Biotech, Inc. |
| Nov 22, 2024 | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. | Class II | Nipro Renal Soultions USA, Corporation |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | Clarity Precision Grip Attachments, for use in orthodontic treatment. Part... | Attachments may not mate with the tooth as intended in the digital treatment design. | Class II | 3M Company - Health Care Business |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Ste... | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was ... | Class II | Cook Biotech, Inc. |
| 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 | 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) 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 | 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) 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 | 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) FREE FLAP BASIC SET-U... | 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) ENDOSCOPIC SKULL BASE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... | Class II | Abbott Medical |
| 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 | 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 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) 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) 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 | 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 | 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 | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION P... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OE... | 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 | 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) CERVICAL 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 | OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3... | 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) ENSEMBLE RACHIS-LF, R... | 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) OPEN HEART CDS-LF, RE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| 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 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... | Class I | Nova Biomedical Corporation |
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.