Browse Device Recalls

2,805 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,805 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 2,805 FDA device recalls in 2025.

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DateProductReasonClassFirm
Dec 31, 2025 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... Products were mislabeled as the 6mm product but included the 5 mm product. Class II Centinel Spine, Inc.
Dec 31, 2025 Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. A systematic positive bias of up to 20% was identified across the reportable potassium range, res... Class II Medica Corporation
Dec 31, 2025 BEAR Implant. Model Number: 1000. Incorrect expiration date on label that extends beyond the product's documented/approved shelf li... Class II Miach Orthopaedics
Dec 31, 2025 Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET... Under circumstances involving exposure to particular chemicals and mechanical forces, the male lu... Class II Medline Industries, LP
Dec 30, 2025 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Nu... Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may resu... Class II Intuitive Surgical, Inc.
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2025 PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 Incorrect expiration date Class II Cerapedics, Inc.
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 26, 2025 Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PREGNANCY TEST 24CT Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CO... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE ... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, A... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Chest Drainage Units and Accessories: Product Code Description 1. 88885... The firm is updating the IFU to clarify the intended patient population for the identified chest ... Class II Cardinal Health 200, LLC
Dec 24, 2025 Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit S... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Ki... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit i... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY,... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit S... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU D... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Dec 24, 2025 GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16,... There is a potential intermittent issue on certain Omni Legend systems that can result in a strea... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 24, 2025 Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Dec 24, 2025 Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit i... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANG... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 23, 2025 CellMek SPS Sample Preparation System, REF: C44603, with software Sample preparation system designed to automate staining, lysing, cell washing has a software erro... Class II Beckman Coulter, Inc.
Dec 23, 2025 Focalyx Fusion Software device that is an accessory for image-guided interventional and diagnostic procedures in... Class II Focalyx Technologies, LLC.
Dec 22, 2025 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Liv... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Patient Information Center iX; Software Version Number: 4.5.0 A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... Class II Philips North America
Dec 22, 2025 Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 E... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medi... BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packagi... Class II LSL Healthcare Inc.
Dec 19, 2025 Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemol... Product not cleared by the FDA. Class II Altruan GmbH
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Alphenix INFX-8000C, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement... Class II Canon Medical System, USA, INC.
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 19, 2025 Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococ... Product not cleared by the FDA. Class II Altruan GmbH
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 Alphenix INFX-8000V, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement... Class II Canon Medical System, USA, INC.
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 Alphenix INFX-8000H, interventional fluoroscopic x-ray system It has been discovered that there is a possibility that the fixing screws of the ceiling movement... Class II Canon Medical System, USA, 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.