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.

Mar 13, 2025 Other Medical Devices Nationwide View Details →

Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Stryker GmbH

Class I - Dangerous

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Mar 28, 2025 Other Medical Devices Nationwide View Details →

Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

Welch Allyn CP150 Electrocardiograph:

Baxter Healthcare

Class I - Dangerous

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.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Brand 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

Abbott Diagnostics Scarborough

Class I - Dangerous

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

Mar 4, 2025 Other Medical Devices Nationwide View Details →

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

Welch 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.

Baxter Healthcare

Class I - Dangerous

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Mar 21, 2025 Other Medical Devices View Details →

Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;

Stryker GmbH

Class I - Dangerous

The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.

Mar 28, 2025 Other Medical Devices Nationwide View Details →

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Philips North America

Class I - Dangerous

Potential for collimator to fall as a result of incorrect installation.

Mar 10, 2025 Other Medical Devices Nationwide View Details →

Welch 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) 84NTVEC-B; 27) 84NTVX2-6; 28) 84NTVX2-B; 29) 84NTVX2-US; 30) 84NTVXC-4; 31) 84NTVXC-B; 32) 84NTVXP-B; 33) 84NXVEC-4; 34) 84NXVEC-6; 35) 84NXVEC-B; 36) 84XTVXC-2; 37) 84XTVXC-B; 38) 85MTVE3-2; 39) 85MTVE3-4; 40) 85MTVE3-B; 41) 85MTVE3-US; 42) 85MTVEC-4; 43) 85MTVEC-B; 44) 85MTVEP-2; 45) 85MTVEP-B; 46) 85MTVX3-4; 47) 85MTVX3-B; 48) 85MTVX3-US; 49) 85MTVXC-6; 50) 85MTVXC-B; 51) 85MTVXX-6; 52) 85MXVEC-2; 53) 85MXVEC-4; 54) 85MXVEC-B; 55) 85MXVEP-4; 56) 85NTVE3-4; 57) 85NTVE3-6; 58) 85NTVE3-B; 59) 85NTVE3-US; 60) 85NTVEC-B; 61) 85NTVEP-2; 62) 85NTVEP-6; 63) 85NTVEP-B; 64) 85NTVX3-6; 65) 85NTVX3-B; 66) 85NTVX3-US; 67) 85NTVXC-B; 68) 85NTVXP-2; 69) 85NTVXP-B; 70) 85NXVEC-4; 71) 85NXVEC-B; 72) 85NXVEP-6.

Baxter Healthcare

Class I - Dangerous

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Mar 21, 2025 Other Medical Devices View Details →

Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F

MEDLINE INDUSTRIES, LP - Northfield

Class I - Dangerous

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Mar 3, 2025 Other Medical Devices Nationwide View Details →

← Back to All Medical Devices Recalls