Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A; 8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 9) CATH LAB PACK, Model Numbe
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- 2025-04-23FDA-DeviceChannel Medsystems, Inc.Class IIBrand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects,
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
- 2025-04-23FDA-DeviceMicro-X Ltd.Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury d
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- 2025-04-23FDA-DeviceMicro-X Ltd.Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury d
Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode.
- 2025-04-23FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceAbbott Diagnostics Scarborough, Inc.Class IIBrand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- 2025-04-23FDA-DeviceThoratec LLCClass IHeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
- 2025-04-23FDA-DeviceConformis Inc.Class IIrestor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B; 5) ) Product Code/Part # 67NCTP-B; 6) ) Product Code/Part # 67NCTP-B-ECG3A; 7) ) Product Code/Part # 67NCTX-B; 8) ) Product Code/Part # 67NXEX-B; 9) ) Product Code/Part # 67NXTP-B; 10) ) Product Code/Part # 67NXTP-B-ECG3A; 11) ) Product Code/Part # 67NXTX-B; 12)
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75MT-BR; 19) 75MX-B; 20) 75RE-B; 21) 75RT-B; 22) 75WE-B; 23) 75WT-B.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10) 84MTVX2-6; 11) 84MTVX2-B; 12) 84MTVX2-US; 13) 84MTVXC-4; 14) 84MTVXC-B; 15) 84MTVXP-2; 16) 84MTVXP-4; 17) 84MTVXP-B; 18) 84MTVXX-2; 19) 84MXVEC-4; 20) 84MXVEC-B; 21) 84MXVEP-4; 22) 84MXVEP-B; 23) 84NTVE2-6; 24) 84NTVE2-B; 25) 84NTVE2-US; 26) 84NT
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- 2025-04-23FDA-DeviceStraumann USA LLCClass IITLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn CP150 Electrocardiograph:
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn CONNEX Accessory Power Management Stand:
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-23FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-23FDA-DeviceAbbott MedicalClass IIAveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
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