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St Jude Medical Cardiac Rhythm Management Division

St Jude Medical Cardiac Rhythm Management Division Recalls

All product recalls associated with St Jude Medical Cardiac Rhythm Management Division.

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Recall Summary

Total Recalls

398

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 201–220 of 398 recalls

St Jude Medical Cardiac Rhythm Management Division: Merlin@home RF Remote Monitoring Transmitter, Model EX115...

Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.

Class IIModerate

FDADec 18, 2014Nationwide• St Jude Medical Cardiac Rhythm Management Division

Stryker Craniomaxillofacial Division: MEDPOR BARRIER Sheets Orbital Floor Implant Product U...

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Class IIModerate

FDADec 17, 2014Nationwide• Stryker Craniomaxillofacial Division

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Stryker Craniomaxillofacial Division: MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Pa...

Potential for implant damage, implant cracking off/breaking intra-operatively.

Class IIModerate

FDADec 17, 2014Nationwide• Stryker Craniomaxillofacial Division

Stryker Craniomaxillofacial Division: MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR...

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Class IIModerate

FDADec 17, 2014Nationwide• Stryker Craniomaxillofacial Division

Stryker Craniomaxillofacial Division: MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Tita...

Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.

Class IIModerate

FDADec 17, 2014Nationwide• Stryker Craniomaxillofacial Division

Maquet Datascope Corp - Cardiac Assist Division: CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aort...

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

Class IIModerate

FDADec 16, 2014Nationwide• Maquet Datascope Corp - Cardiac Assist Division

Cooper Vision Caribbean Corp.: Soft Contact Lens

Portions of the lots may contain units with an incorrect lens axis condition.

Class IIModerate

FDAOct 28, 2014Nationwide• Cooper Vision Caribbean Corp.

Low Water Cut-Off Control Units (Fluid Handling) – Fire hazard (2014)

Fire/Burn Risk

This recall involves McDonnell and Miller series 750 Low Water Cut-Off control units, which in connection with a water level sensor, are used as a primary or secondary safety control on hot water or steam boilers to signal the boiler to provide protection in low water conditions. The unit is mounted on the outside of a boiler, generally near the boiler's main electrical panel. They are black and measure about 6 inches high x 5 inches wide x 2 1/2 inches deep. The units have a green LED "On" light, a red LED "Low Water" light and test and manual reset buttons on the top. "McDonnell and Miller," "Guard Dog," "Low Water Cut-Off" and model numbers 750-MT-120, 751-MT-120, 751P-MT-120 or 752P-MT-24 are printed on a white label on the outside of the unit. Date codes G41 or H41 are inked on the inside back plate.

CPSCOct 9, 2014Nationwide• Fluid Handling LLC, of Morton Grove, Ill., a division of Xylem Inc.

Haleigh Wire Dome Pendant (Rejuvenation) – Injury potential (2014)

This recall involves Rejuvenation Haleigh Wire Dome Pendant hanging lamps sold in three different finishes: Lacquered polished brass, oil rubbed bronze and polished nickel. The lamp is a parabolic-shaped dome made of solid brass with an external wire structure and a ceiling plate. The lamp cord can vary in length from 14 inches to 200 inches. The lamps are illuminated by one 150-watt bulb. The lamp's canopy measures 5 ¼ inches wide and 12 inches long for item # A5908 or 8 inches long for item # A5909. The item number can be found on a white label inside the ceiling plate.

CPSCOct 9, 2014Nationwide• Rejuvenation Inc., of Portland, Ore., a division of Williams-Sonoma

Cooper Vision Caribbean Corp.: ProClear Toric contact lenses are made from a mat...

Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

Class IIILow

FDASep 17, 2014Nationwide• Cooper Vision Caribbean Corp.

Abbott Ireland Diagnostics Division: ARCHITECT Total T3 Reagent Kit (7K64) consists of: - ...

17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.

Class IIModerate

FDASep 11, 2014Nationwide• Abbott Ireland Diagnostics Division