Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2026 | Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. | Increased rate of out-of-specification endotoxin results. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Mar 19, 2026 | B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Mode... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| 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 | B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Numb... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. M... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| 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 | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, R... | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting... | Class I | Medical Action Industries, Inc. 306 |
| 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 | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CATH LAB kit. Model Number: SACL75AM. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CATH LAB kit. Model Number: SACL75-01. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| Mar 13, 2026 | Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. | Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a l... | Class I | AVID Medical, Inc. |
| 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 | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... | Class I | Insulet Corporation |
| 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 | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48... | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Class I | Intuitive 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.