Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYK... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... | Devices which did not undergo thermoforming could deform and lose performance. | Class II | Olympus Corporation of the Americas |
| Jan 7, 2026 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II | Olympus Corporation of the Americas |
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | The mix up of the impression caps provided in the package. The provided impression caps are magen... | Class III | Straumann USA LLC |
| Jan 6, 2026 | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 5, 2026 | Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Jan 5, 2026 | Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A... | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal S... | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Jan 5, 2026 | Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM ... | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI... | Due to a modification by a vendor and may be reinstalled without properly engaging the outside re... | Class II | Raz Design Inc |
| Jan 5, 2026 | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ... | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing... | Class II | Biomerieux Inc |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Jan 2, 2026 | ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 26... | Due a design issue where the navigated array connection geometry is incorrect. | Class II | Alphatec Spine, Inc. |
| Jan 2, 2026 | Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. | Tyvek bag seal issue which may compromise sterility of the kit. | Class II | AVID Medical, Inc. |
| 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 |
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.