Browse Device Recalls
34,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,057 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 34,057 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may resu...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 | 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 | 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 | 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 | 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. |
| Dec 19, 2025 | NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... | 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 | Portex Spinal Tray, Item No. A3729-24 A3595 | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Mo... | Due to products not having FDA Premarket authorization to be distributed within the United States. | Class II | MicroPort Orthopedics Inc. |
| Dec 19, 2025 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual scre... | Class II | Tornier, Inc |
| Dec 19, 2025 | Clearest Strep-A Cassette Test. Test to determine the presence of group A str... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 19, 2025 | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P... | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... | 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 | NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... | To remove the software applications from certain CT systems as the applications have not received... | Class II | Siemens Medical Solutions 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.