Browse Device Recalls
40,358 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40,358 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 40,358 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 7, 2026 | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 | Due to software issue with ultrasound system, doppler sample is displayed shallower than its actu... | Class II | Philips Ultrasound, LLC |
| Aug 7, 2026 | PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-10... | The potential for the device to detach at the junction between the spring arm and suspension arm... | Class II | Maquet SAS |
| Aug 7, 2026 | Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501... | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and ef... | Class II | Happiest Baby, Inc |
| Aug 7, 2026 | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101... | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and ef... | Class II | Happiest Baby, Inc |
| Aug 7, 2026 | Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model... | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of ca... | Class II | Atrium Medical Corporation |
| Aug 7, 2026 | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Nu... | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of ca... | Class II | Atrium Medical Corporation |
| Aug 7, 2026 | Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Nu... | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of ca... | Class II | Atrium Medical Corporation |
| Aug 7, 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 7, 2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... | Class II | Philips North America Llc |
| Aug 6, 2026 | Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1... | Software system may associate image data from one patient with another patient's record, potenti... | Class II | Volcano Corp |
| Aug 6, 2026 | Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex M... | Wheels may come loose when module is being pushed or pulled during movement or transportation, af... | Class II | Heidelberg Engineering GmbH |
| Aug 6, 2026 | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo ... | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include pat... | Class I | Given Imaging Ltd. |
| Aug 6, 2026 | Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical la... | Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a sp... | Class II | Lutronic Corporation |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 6, 2026 | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... | There is potential for a delay in AF Burden Alert notification affecting the server software whic... | Class II | Boston Scientific Corporation |
| Aug 6, 2026 | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Number... | The linear actuator and rotational lock mechanism components may experience a mechanical failure ... | Class II | IMRIS Imaging Inc |
| Aug 6, 2026 | ORT200, operating room table, including the ORT200 Covered Table Assembly, Re... | The linear actuator and rotational lock mechanism components may experience a mechanical failure ... | Class II | IMRIS Imaging Inc |
| Aug 5, 2026 | Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 | Hemodialysis concentrates contain high endotoxin levels | Class II | Nipro Renal Soultions USA, Corporation |
| Aug 5, 2026 | MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.... | Hemodialysis concentrates contain high endotoxin levels | Class II | Nipro Renal Soultions USA, Corporation |
| Aug 5, 2026 | Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+22... | Hemodialysis concentrates contain high endotoxin levels | Class II | Nipro Renal Soultions USA, Corporation |
| Aug 5, 2026 | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 | Hemodialysis concentrates contain high endotoxin levels | Class II | Nipro Renal Soultions USA, Corporation |
| Aug 4, 2026 | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number... | When a bolus is included in a treatment plan and sent for secondary dose calculation, the softwar... | Class II | PTW FREIBURG |
| Aug 4, 2026 | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Ca... | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on t... | Class II | B Braun Medical Inc |
| Aug 4, 2026 | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digit... | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X... | Class II | Canon Medical System, USA, INC. |
| Aug 3, 2026 | Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANA... | Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the m... | Class II | Beckman Coulter Mishima K.K. |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected the accuracy of the... | Class II | Baxter Healthcare Corporation |
| Jul 31, 2026 | JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... | Class II | Jenavalve Technology Inc. |
| Jul 31, 2026 | JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... | Class II | Jenavalve Technology Inc. |
| Jul 31, 2026 | JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to ... | Class II | Jenavalve Technology Inc. |
| Jul 31, 2026 | New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Lev... | Gowns do not consistently meet the minimum liquid-barrier performance required. | Class II | New York Embroidery Studio, Inc. |
| Jul 31, 2026 | Convenience kits CATARACT PACK DYNJ59881A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (US... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 31, 2026 | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Enterprise Archive V8, software product for receiving, archiving, and sending... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Philips Patient Information Center iX REF:866389 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 31, 2026 | Workflow Core Services V8, intended to provide set of services for storage an... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 | The 6Fr suction catheter could not pass through the samples smoothly. | Class II | WELL LEAD MEDICAL CO. LTD |
| Jul 31, 2026 | Core Services Hub V8, a set of backend services including Cross Enterprise (X... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 ... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 31, 2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving,... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 ... | The packaging may not consistently maintain sterile barrier integrity. | Class II | Maquet Cardiopulmonary Gmbh |
| Jul 31, 2026 | MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System... | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. | Class II | Bayer Medical Care, Inc. |
| Jul 31, 2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the stor... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Philips PIC iX Essentials REF:867093 | Due to software malfunction, patient information system may freeze and become unresponsive. | Class II | Philips North America |
| Jul 31, 2026 | Centricity PACS Server V7, intended for managing digital medical images and a... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
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.