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Abbott Laboratories Inc. (St Jude Medical)

Abbott Laboratories Inc. (St Jude Medical) Recalls

All product recalls associated with Abbott Laboratories Inc. (St Jude Medical).

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Recall Summary

Total Recalls

1000

Past Year

276

Class I (Serious)

242

Most Recent

Jan 2026

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 1501–1520 of 4099 recalls

Abbott Laboratories Inc. (St Jude Medical): v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate ...

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

FDAMay 5, 2021Nationwide• Abbott Laboratories Inc. (St Jude Medical)

Abbott Laboratories Inc. (St Jude Medical): WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007...

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

FDAMay 5, 2021Nationwide• Abbott Laboratories Inc. (St Jude Medical)

Garlic Alfredo Sauce (Kerry) – Unsafe Ingredient (2021)

Food was made with a non-food grade anti-foamer ingredient.

Class IIModerate

1...74 757677 78...205

Page 76 of 205Next

FDA

May 4, 2021

AZ, CO, OK +2 more

• Kerry Global Technology Innovation Center

Creamy Alfredo Sauce (Kerry) – Unsafe Ingredient (2021)

Food was made with a non-food grade anti-foamer ingredient.

Class IIModerate

FDAMay 4, 2021AZ, CO, OK +2 more• Kerry Global Technology Innovation Center

RanD S.r.l. Strada Statale 62 Medolla Italy: Hang&Go (kit for hyperthermic perfusion), Reference Code ...

The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

FDAApr 30, 2021FL, IL, TN +1 more• RanD S.r.l. Strada Statale 62 Medolla Italy

RanD S.r.l. Strada Statale 62 Medolla Italy: Ch24 round silicone catheter, Diameter: 8 mm, Perforated ...

The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

FDAApr 30, 2021FL, IL, TN +1 more• RanD S.r.l. Strada Statale 62 Medolla Italy

Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland: Randox RX Imola Analyser with ISE, Catalog Numbers RX4900...

An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

FDAApr 28, 2021Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Circulatory Technology Inc.: The Better-Bladder (BB), part of extracorporeal membrane ...

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

FDAApr 27, 2021Nationwide• Circulatory Technology Inc.

Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy: Olympus Sterile Optical Laser Fiber, single use and reusable

Product sterility is potentially compromised.

FDAApr 27, 2021Nationwide• Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy

Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy: Quanta System Sterile Optical Laser Fiber, single use

Product sterility is potentially compromised.

FDAApr 27, 2021Nationwide• Quanta System, S.p.A. Via Acquedotto 109 Samarate Italy

Abbott Laboratories Inc. (St Jude Medical): NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model ...

Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.

FDAApr 22, 2021Nationwide• Abbott Laboratories Inc. (St Jude Medical)

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation (Treatment Planning System) Model Number RaySt...

Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.

FDAApr 21, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany: Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, S...

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

FDAApr 21, 2021Nationwide• INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany

INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany: Coaxial Interventional Needle, ITP innotom.com, CE 0297, ...

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

FDAApr 21, 2021Nationwide• INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany

Blanched Penne Rigati (Marzetti) – Undeclared Egg (2021)

Undeclared Allergen

Undeclared Egg Allergen

Class IHigh

FDAApr 14, 2021CA, IN• T MARZETTI INNOVATION CENTER

DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico: DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONL...

failed rivet at the chafe tab of arm sling.

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico: DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, ...

failed rivet at the chafe tab of arm sling.

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico: DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, ...

failed rivet at the chafe tab of arm sling.

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico: DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, ...

failed rivet at the chafe tab of arm sling.

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

Love & Peas Meal Replacement (Nature's Sunshine) - Potential Milk Trace (2021)

The firm was notified by its ingredient supplier of Medium Chain Triglycerides (MCT) that the ingredient potentially contained traces of milk. This affected two of the firm's products that are marketed and sold as vegan and dairy-free.

Class IHigh

FDAApr 12, 2021Nationwide• NATURE'S SUNSHINE PRODUCTS