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.

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DateProductReasonClassFirm
Mar 19, 2026 Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Increased rate of out-of-specification endotoxin results. Class II Integra LifeSciences Corp. (NeuroSciences)
Mar 19, 2026 Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Increased rate of out-of-specification endotoxin results. Class II Integra LifeSciences Corp. (NeuroSciences)
Mar 19, 2026 Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (I... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 19, 2026 Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. Increased rate of out-of-specification endotoxin results. Class II Integra LifeSciences Corp. (NeuroSciences)
Mar 18, 2026 Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent car... Class II Siemens Healthcare Diagnostics, Inc.
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 TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to re... Class II Smith & Nephew, Inc.
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

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.