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.

Clear
DateProductReasonClassFirm
Mar 25, 2024 RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors... Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to ... Class I SonarMed Inc
Mar 23, 2024 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/7... Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not select... Class II Philips Ultrasound, Inc.
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYN... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DY... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF C... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK101... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 20" Lead Wires, Replacement Part Number: 1067724-2 Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT A... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYN... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS... Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information... Class II Philips North America Llc
Mar 22, 2024 Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte c... Product demonstrates low viscosity. Class II Parker Laboratories, Inc.
Mar 22, 2024 Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 48" Lead Wires, Replacement Part Number: 1067724-4 Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), RE... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H7... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H74... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific Corporation
Mar 21, 2024 Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749... An increase in complaints related to an inability to advance the guidewire through the lumen of t... Class I Boston Scientific 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.