Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, ... | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and... | Class II | Merit Medical Systems, Inc. |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. ... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SI... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 10, 2026 | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-51... | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| 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 | 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 |
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.