Browse Device Recalls
34,608 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,608 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 34,608 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm,... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-2... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 18, 2026 | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm... | The catheter inflation tag attached to the device may contain an incorrect part number with incor... | Class II | Diversatek Healthcare |
| Mar 17, 2026 | Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art... | A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... | Class II | Straumann USA LLC |
| Mar 17, 2026 | Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ... | A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... | Class II | Straumann USA LLC |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline or Centurion medical convenience kits, containing Webcol Large Alcoho... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Flamingo Funnel Large, Model Number SQ20012-03 | Certain lots of product were associated with a manufacturing nonconformance involving use of a no... | Class II | SurgiSmoke Solutions |
| Mar 16, 2026 | Flamingo Funnel Medium, Model Number SQ20012-02 | Certain lots of product were associated with a manufacturing nonconformance involving use of a no... | Class II | SurgiSmoke Solutions |
| Mar 16, 2026 | Access Total T4 Calibrator, Catalog No. 33805 | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative... | Class II | Beckman Coulter, Inc. |
| Mar 16, 2026 | Flamingo Funnel Small, Model Number SQ20012-01 | Certain lots of product were associated with a manufacturing nonconformance involving use of a no... | Class II | SurgiSmoke Solutions |
| Mar 16, 2026 | CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F | On lot of Sterile Circumcision Kits was distributed without the required sterilization process an... | Class II | Medline Industries, LP |
| Mar 13, 2026 | LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare U... | Customers reported observing unexpectedly elevated results when using certain third-party micro-c... | Class II | Magellan Diagnostics, Inc. |
| Mar 13, 2026 | (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test K... | Customers reported observing unexpectedly elevated results when using certain third-party micro-c... | Class II | Magellan Diagnostics, Inc. |
| Mar 13, 2026 | LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ ... | Customers reported observing unexpectedly elevated results when using certain third-party micro-c... | Class II | Magellan Diagnostics, Inc. |
| Mar 12, 2026 | Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end s... | Product does not have FDA clearance. | Class II | Healthmark Industries Co., Inc. |
| Mar 12, 2026 | iLet Bionic Pancreas, REF: BB1001 | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring ... | Class II | Beta Bionics, Inc. |
| Mar 12, 2026 | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Co... | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start C... | Class II | Linkbio Corp. |
| Mar 12, 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | During 3D acquisitions, lighter and darker patient images may be captured, which may result in le... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 12, 2026 | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Po... | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and re... | Class II | Stryker Sustainability Solutions |
| Mar 12, 2026 | B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic ... | Customers have observed quality control values out of range at the lowest quality control level (... | Class II | Brahms GmbH |
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Mar 11, 2026 | Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - ... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... | Class II | Windstone Medical Packaging, Inc. |
| Mar 11, 2026 | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022... | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PU... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... | Class II | Windstone Medical Packaging, Inc. |
| Mar 11, 2026 | PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 ... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CAT... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOU... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 11, 2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... | Class II | Windstone Medical Packaging, Inc. |
| Mar 11, 2026 | MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters R... | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Class II | ARROW INTERNATIONAL, LLC |
| Mar 10, 2026 | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US | An internal component of the actuators in a certain production batch may not meet the required me... | Class II | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Mar 10, 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 1084900... | During patient examinations, the system may sporadically display a major increase of the x-ray do... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | During patient examinations, the system may sporadically display a 0 x-ray dose administered to... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2026 | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ... | During patient examinations, the system may sporadically display a 0 x-ray dose administered to... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2026 | Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum D... | Due to complaints of device breakage at the traction force gauge to handle joint. | Class II | Clinical Innovations, LLC |
| Mar 9, 2026 | VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68... | There is a possibility of reagent leakage from the specimen container. | Class II | Milestone S.R.L. |
| Mar 9, 2026 | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft ... | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life... | Class II | XTANT Medical Holdings, Inc |
| Mar 9, 2026 | LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number... | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... | Class II | LSL Healthcare Inc. |
| Mar 9, 2026 | LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131 | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... | Class II | LSL Healthcare Inc. |
| Mar 9, 2026 | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... | Class II | LSL Healthcare Inc. |
| Mar 9, 2026 | LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Numb... | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... | Class II | LSL Healthcare 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.