Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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DateProductReasonClassFirm
Mar 19, 2024 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 15, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... Class I Elekta Instrument AB
Mar 14, 2024 VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kit... Class I Biomerieux Inc
Mar 13, 2024 BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... Safety Information: Complaints describe complications/adverse events that include pain, infection... Class I Hologic, Inc
Mar 8, 2024 Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO.... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used f... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, Ster... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. ... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 8, 2024 Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for... Their is the potential for distal tip separation at the proximal marker band of the delivery cath... Class I ROUTE 92 MEDICAL INC
Mar 7, 2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... Class I Fresenius Kabi USA, LLC
Mar 6, 2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hou... Class I Outset Medical, Inc.
Mar 5, 2024 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Co... During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iO... Class I Tandem Diabetes Care, Inc.
Mar 1, 2024 Mojo 2 Full Face Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Phantom 2 Nasal Vented Mask Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Mojo 2 Full Face Non Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle assist system inflow c... Class I Thoratec Corp.
Mar 1, 2024 Mojo Non Vented Full Face Mask with Headgear, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 iQ 2 Nasal Vented Mask Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Mojo Full Face with Headgear, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Mojo 2 Full Face AAV Non Vented Mask, All Sizes Update to contraindications and warning language due to CPAP masks containing magnets. Class I SleepNet Corporation
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle assist system inflow c... Class I Thoratec Corp.
Feb 27, 2024 CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, a... The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... Class I Smiths Medical ASD Inc.
Feb 27, 2024 CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following ... CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following ... Class I Smiths Medical ASD Inc.
Feb 27, 2024 CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the foll... The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intraveno... Class I Smiths Medical ASD Inc.
Feb 26, 2024 Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... Complaints have been received that the device inflation tube detached and/or tore from the main t... Class I MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2024 Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC
Feb 21, 2024 Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... Class I InfuTronix LLC
Feb 20, 2024 Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0... An investigation determined that delivery of the Obsidio embolic using the aliquot technique for ... Class I Boston Scientific Corporation
Feb 19, 2024 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Feb 19, 2024 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Feb 13, 2024 GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECAR... DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver ... Class I DeRoyal Industries Inc
Feb 12, 2024 ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Nu... Teleflex is initiating this voluntary recall for the above-mentioned products due to reports rece... Class I ARROW INTERNATIONAL Inc.
Feb 12, 2024 Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Boston Scientific has identified a tooling error in manufacturing which may have caused delaminat... Class I Boston Scientific Corporation
Feb 7, 2024 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, RE... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 7, 2024 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP,... When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may... Class I Smiths Medical ASD Inc.
Feb 2, 2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS909... Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractur... Class I Medos International Sarl
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 18 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Safe Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Lock Catheter Ext. 12 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Catheter Ext. 6 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 23, 2024 stay-safe /Luer Lock Adapter 4 in The peroxide cross-linked tubing has leachables identified as NDL PCBAs. Class I Fresenius Medical Care Holdings, Inc.
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection ... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 22, 2024 Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... Potential for catheter disconnection from the patient line stopcock connectors. Class I Medtronic Neurosurgery
Jan 16, 2024 MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: ... MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recall... Class I Avanos Medical, 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.