Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

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DateProductReasonClassFirm
Aug 4, 2023 DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, R... Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 4, 2023 HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhal... Product dispositioned for scrap for sterility failure investigation that was inadvertently shippe... Class I MEDLINE INDUSTRIES, LP - Northfield
Aug 4, 2023 DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 Orthopedic device components were not subjected to final sterilization before shipment, which if ... Class II Encore Medical, LP
Aug 3, 2023 MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible wit... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Che... Class II Randox Laboratories Ltd.
Aug 3, 2023 GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 Some surgical glove sterile pouches were not completely sealed. Class II Ansell Healthcare Products LLC
Aug 3, 2023 Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for ... It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide e... Class II Accuray Incorporated
Aug 3, 2023 MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Gen... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 3T Heater Cooler System, REF: 16-02-85 The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance sch... Class II LivaNova Deutschland GmbH
Aug 3, 2023 MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 S... Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 3, 2023 NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V2... Some surgical glove sterile pouches were not completely sealed. Class II Ansell Healthcare Products LLC
Aug 3, 2023 MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the ti... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 2, 2023 Incisive CT, software version 5.0 Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: C... Class II Philips Healthcare
Aug 1, 2023 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four i... Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing ... Class II Avanos Medical, Inc.
Aug 1, 2023 GS70 Salus Surgical Table, Product Code 18-070-70 When the control of the operating table was used in Bluetooth mode, the operating table continued... Class II Skytron, LLC
Aug 1, 2023 GS70H Salus Surgical Table, Product Code 18-071-70 When the control of the operating table was used in Bluetooth mode, the operating table continued... Class II Skytron, LLC
Aug 1, 2023 SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and effi... Class II SynCardia Systems LLC
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... Class II Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting ... Class II Datascope Corp.
Jul 31, 2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... The incorrect product labeling was applied to the product indicating the wrong size of product. Class II Medtronic Sofamor Danek USA Inc
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were identifying autofill failure conditions on the devices causing pump stops. Class I Datascope Corp.
Jul 31, 2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Card... Class I Datascope Corp.
Jul 31, 2023 Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class II B. Braun Medical, Inc.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms ... Class I Datascope Corp.
Jul 31, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-080... Users were reporting that the device was not charging as expected. It was discovered that users w... Class I Datascope Corp.
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Henke-Ject-2 part luer sterile single use syringes - used for intravenous, in... Sterile barrier might be damaged compromising the sterility of the device. Class II Wolf, Henke Sass, Gmbh
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-XT190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M00310142... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M00310143... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466,... The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... Class II Aomori Olympus Co., Ltd.
Jul 27, 2023 Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M00310146... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M00310162... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M00310144... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V Recent reports of patient infection. Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Models BF-MP190F. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Bronchovideoscope, Model BF-Q180-AC Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... Class II Olympus Corporation of the Americas
Jul 27, 2023 Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M00310148... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II 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.