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St Jude Medical CRMD

St Jude Medical CRMD Recalls

All product recalls associated with St Jude Medical CRMD.

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Recall Summary

Total Recalls

436

Past Year

17

Class I (Serious)

64

Most Recent

Dec 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 401–420 of 436 recalls

St Jude Medical CRMD: St. Jude Medical APS III Programmer, used in combination ...

St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

FDAOct 6, 2006IN• St Jude Medical CRMD

St Jude Medical CRMD: St. Jude Medical Merlin PCS Programmer, used in combinati...

St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

FDAOct 6, 2006IN• St Jude Medical CRMD

St. Jude Medical Daig Division: FastCath Transseptal Catheter Introducers with Hemostasis...

Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.

Page 21 of 22Next

FDAOct 5, 2006Nationwide• St. Jude Medical Daig Division

St. Jude Medical Daig Division: The affected device is labeled Angio-Seal Vascular Closur...

The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.

FDAJun 7, 2006Nationwide• St. Jude Medical Daig Division

St Jude Medical CRMD: CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 4...

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Direct SL, Models 410110, 410111, 410112, 410113, 410...

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Valve Bypass Tool (VBT), Model 410192

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Slitter, Model 410191

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St Jude Medical CRMD: CPS Implant Kit, Model 410190

Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.

FDAJun 1, 2006AZ, CA, IN +3 more• St Jude Medical CRMD

St. Jude Medical Daig Division: St. Jude AGILIS Steerable Introducer, Reorder number 4083...

St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.

FDAApr 14, 2006AL, AK, AZ +33 more• St. Jude Medical Daig Division

Little Tikes Animal Flashlights – Lead Paint (2006)

The Glowin' Dino Flashlight and the Glowin' Doggy Flashlight are about 9 inches long and make an electronic sound when switched on. The green dinosaur roars, and the white and brown dog barks. Only flashlights with the following date codes are included in the recall: LC5H161, LC5H291, LC5I031, LC5I091, LC5I131, LC5J061, LC5J231, and LC5J311. The date codes are found on the bottom of the flashlights. Units that do not contain these codes or other animal flashlight characters made by The Little Tikes Co. are not included in this recall. Also, units that have an "R" at the end of the date code are not included in the recall.

CPSCMar 1, 2006Nationwide• The Little Tikes Co., of Hudson, Ohio

St. Jude Medical Daig Division: Sheath Obturator, introducer, catheter. Obturator Access...

A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.

FDASep 20, 2005CA, FL, IL +7 more• St. Jude Medical Daig Division

St. Jude Medical Daig Division: Angio-Seal Vascular Closure Device. Ref 610109. 6F STS ...

Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.

FDAAug 22, 2005Nationwide• St. Jude Medical Daig Division

E.M.S. Electro Medical Systems SA Chemin de la Vuarpilliere 31 Nyon, Vaud Switzerland: Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-...

Handpiece may become dislodged causing cable damage and possible electric shock.

FDAMar 16, 2005Nationwide• E.M.S. Electro Medical Systems SA Chemin de la Vuarpilliere 31 Nyon, Vaud Switzerland

TV/VCR Cart (Sauder) – Structural Stability Risk (2004)

The recalled TV/VCR carts are white, light brown and light reddish brown; have decorative hardware and trim; and are about 29 inches wide, 17 inches deep, and 25 inches high. The carts are equipped with a top shelf for a television 20 inches or smaller and a middle shelf for a VCR and a lower storage area. The recalled carts include models 3355, 6355, 7755, 9855 and 9755, which can be found on the instruction book that came with the cart.

CPSCSep 28, 2004Nationwide• Sauder Woodworking Co., of Archbold, Ohio

St. Jude Medical/Daig Division: Telesheath Left Atrial Introducer System Right Superior. ...

St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.

FDAAug 4, 2004Nationwide• St. Jude Medical/Daig Division

Bamboo Torch (Jo-Ann Stores) – Potential Fire Risk (2004)

The bamboo torch is made of bamboo and stands about five feet tall. The oil canister is housed at the top and the bottom has a spiked tip to stick into the ground. The oil canister is removable and has a black metal top with a hole for the wick to stick out. Instructions and warnings for the use of the product are written on the outside of the oil canister.

CPSCJul 15, 2004Nationwide• Jo-Ann Stores Inc., of Hudson, Ohio

Hudson Respiratory Care Inc: Concha IV Plus Heated Humidifier

Software malfunction. The humidifier did not retain the clinician selected default settings for temperature gradient, after the unit had been placed in the "pause" mode.

FDAApr 20, 2004Nationwide• Hudson Respiratory Care Inc

TV/VCR Carts (Sauder) – Tipping Hazard (2004)

These TV/VCR carts were sold in a kit to be assembled by consumers. They are identical in design and construction, but not color. One model is a light-colored oak finish, and the other model is a dark-colored cherry finish. The TV/VCR carts are about 29.5 inches wide, 18 inches deep and 27 inches high. The carts are equipped with a top shelf intended to support up to a 27-inch television, a middle shelf intended to hold a VCR and a lower storage area intended to hold VCR tapes and equipment. This cart is intended to hold a TV that weighs 95 pounds or less. This includes most 24-inch and smaller TVs, and may include some 27-inch TVs. The products were provided with shelves for holding VHS tapes that were to be installed on the inside of the two hinged doors enclosing the lower storage area. The recalled carts have four removable casters attached to each bottom corner of the cart. The TV/VCR carts included in the recall are models 2655 and 2755. The model number is not on the cart, but it is on the instruction booklet that came with the cart.

CPSCApr 5, 2004Nationwide• Sauder Woodworking Co., of Archbold, Ohio

Subwoofers (Madrigal) – Speaker Design Problem (2002)

The recalled Revel B-15 subwoofers have an outer cabinet with a black or gray speaker grill on the front and are about 20 inches in width, height, and depth. The brand name "Revel" is printed on the bottom left of the rear panel and "PERFORMA B15 SUBWOOFER" is printed on the bottom right.

CPSCDec 26, 2002Nationwide• Madrigal Audio Laboratories, Inc., of Middletown, Conn.