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.

Clear

Date	Product	Reason	Class	Firm
Dec 15, 2025	Allura Xper FD10/10; Model Number: 722005;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M...	The console label for affected devices is missing the "DANGER" symbol.	Class II	LEASEIR TECHNOLOGIES SLU
Dec 15, 2025	Allura Xper FD20/20; Model Number: 722038;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD10/10; Model Number: 722011;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001...	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the...	Class II	ICU Medical, Inc.
Dec 15, 2025	ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ...	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the...	Class II	ICU Medical, Inc.
Dec 15, 2025	Allura Xper FD10; Model Number: 722003;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Product Name: Allura Xper FD10C; Model number: 722001;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD20; Model Number: 722028;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD10/10; Model Number: 722027;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	Allura Xper FD10F; Model Number: 722002;	Philips has identified that in a limited number of impacted systems the drip tray beneath the coo...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 15, 2025	da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ...	Access Port System tray may develop cracks potentially resulting in a sterility breach.	Class II	Intuitive Surgical, Inc.
Dec 15, 2025	Estrone RIA, REF: DSL8700	The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause ...	Class II	Immunotech A.S.
Dec 14, 2025	Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ...	Due to a manufacturing issue and electrical grounding of systems.	Class II	Elekta, Inc.
Dec 12, 2025	Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ...	Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi...	Class II	Integra LifeSciences Corp. (NeuroSciences)
Dec 12, 2025	Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Ki...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, ...	due to a defect associated with the conductivity values of the solution used to calibrate meters ...	Class II	NIPRO Technical Services, Inc.
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, ...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIA...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.	It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead...	Class II	Philips North America Llc
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni...	Due to an error when defining a new stereotactic reference that users fail to first change an alr...	Class II	Elekta, Inc.
Dec 12, 2025	Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ...	Six (6) identified software issues which may result in the following: system keeps restarting, AM...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.	Fungal contamination of affected lot with Parengyodontium album.	Class II	Hologic, Inc
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Philips Azurion system; Software Version Number: R3.1;	Philips has identified two (2) software issues affecting device systems that may result in loss o...	Class II	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 12, 2025	Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ing...	Due to damage to outer tray that can potentially compromise the sterile barrier	Class II	Bard Peripheral Vascular Inc
Dec 12, 2025	Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni...	Due to an error when defining a new stereotactic reference that users fail to first change an alr...	Class II	Elekta, Inc.
Dec 12, 2025	Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA...	Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca...	Class II	Medline Industries, LP
Dec 12, 2025	Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN...	Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi...	Class II	Integra LifeSciences Corp. (NeuroSciences)
Dec 11, 2025	Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	The product is used for the evaluation of the intrinsic coagulation pathway, ...	Potential for microbial contamination.	Class II	Instrumentation Laboratory
Dec 11, 2025	Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 8155...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: ...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 11, 2025	Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23	There is the potential for extended length of the blade obturator after assembly into the cannula...	Class II	Applied Medical Resources Corp
Dec 11, 2025	Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558...	Customers may experience inaccurate test results by observing a higher frequency of classificatio...	Class II	Fujirebio Diagnostics, Inc.
Dec 10, 2025	MAXXUS, System, Tomography, Computed, Emission	GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua...	Class II	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Dec 10, 2025	Mazor X robotic guidance system REF: TPL0059	Software errors that can result in incorrect surgical instrument positioning during spinal surgery.	Class II	Mazor Robotics Ltd

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.