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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

100

Class I (Serious)

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 821–840 of 2670 recalls

WorkMate Claris Upgrade Kit (Abbott) – Software Functionality Loss (2021)

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)

WorkMate Claris Upgrade Kit (Abbott) – Software Functionality Loss (2021)

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)

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specs (2021)

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Class IIILow

1...40 414243 44...134

Page 42 of 134Next

FDA

May 4, 2021

Nationwide

• Dr. Reddy's Laboratories, Inc.

Olmesartan Medoxomil Tablets (Ascend) – Foreign Tablet (2021)

Presence of Foreign Tablet/Capsule

Class IIILow

FDAApr 29, 2021Nationwide• Ascend Laboratories LLC

RX Imola Analyser (Randox) – Software Processing Issue (2021)

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

Better-Bladder (Circulatory Technology) – Device Collapse Risk (2021)

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.

TERYX Off-Highway Vehicles (Kawasaki) – Fire Hazard (2021)

Fire/Burn Risk

This recall involves 2021 Teryx S LE, Teryx4, Teryx4 LE, Teryx4 S LE, and Teryx4 S LE CAMO. The four-wheel, off-highway utility vehicles were sold in camo, camo gray, green, blue, and red. They have side-by-side seating for two to four people. The Vehicle Identification Number (VIN) is located on the steel frame between the right-front lower A-arm mounts. The model name is printed on the driver's side of the hood or on the left and right front fender. The model names, codes, and VIN ranges can be found in the table below. Model Year Model Name Model Code Partial Non-Sequential VIN Range 2021 TERYX S LE KRF800JMFNN/L 00234 thru 00258 TERYX4 KRT800FMFNN 08097 thru 08097 TERYX4 LE (Camo Gray) KRT800GMFAL 27206 thru 27207 TERYX4 S LE KRT800JMFNL 00672 thru 00770 TERYX4 S LE (Camo Gray) KRT800JMFAN/L 00783 thru 00853 TERYX4 S LE (Camo) KRT800KMFNL 00100 thru 00100

CPSCApr 22, 2021Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A., of Lincoln, Neb.

BRUTE FORCE 750 ATVs (Kawasaki) – Fire Hazard (2021)

Fire/Burn Risk

This recall involves the 2021 BRUTE FORCE 750 4X4I EPS. The four-wheel all-terrain vehicles were sold in camo gray, bright white and camo. The Vehicle Identification Number (VIN) is located on the steel frame between the right-front lower A-arm mounts. The model name and model code are printed on both sides of the airbox cover in front of the operator's seat. The model names, codes, and VIN ranges can be found in the table below. Model Year Model Name Model Code Partial Non-Sequential VIN range 2021 BRUTE FORCE 750 4X4i EPS KVF750GMFNN 19547 thru 190608 BRUTE FORCE 750 4X4i EPS (Camo) KVF750HMFNN 08771 thru 08775 BRUTE FORCE 750 4X4i EPS (Camo Gray) KVF750JMFNN 11478 thru 11484

CPSCApr 22, 2021Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A., of Lincoln, Neb.

NeuroTherm RF Generator (Abbott) – Capacitor Failure (2021)

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)

RayStation (RaySearch) – Clinical Goal Evaluation (2021)

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

Dialysate Concentrate (Medivators) – Manufacturing Anomaly (2021)

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

FDAApr 20, 2021Nationwide• Medivators, Inc.

Asenapine Sublingual 5mg (SigmaPharm) – flavor mix-up (2021)

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Class IIILow

FDAApr 19, 2021Nationwide• SigmaPharm Laboratories LLC

Asenapine Sublingual 10mg (SigmaPharm) – flavor mix-up (2021)

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Class IIILow

FDAApr 19, 2021Nationwide• SigmaPharm Laboratories LLC

Meritor ePowertrains (Meritor) – Stator Wire Problem (2021)

Meritor, Inc. (Meritor) is recalling certain 14Xe ePowertrains part numbers A-3200A2653-657, A-3200D2656-478. The stator assembly wires may have been insufficiently crimped, causing high resistance, overheating, and preventing the high voltage system from starting.

NHTSAApr 16, 2021Nationwide• MERITOR

Dark Chocolate Expresso Beans (Torn & Glasser) - Undeclared Walnuts (2021)

Dark Chocolate walnuts were packed in a container labeled at Dark Chocolate Espresso Beans and does not declare walnuts as an allergen Bottom label with nutritional information is correct for the Dark Chocolate Walnuts.

Class IIModerate

FDAApr 13, 2021AL, AK, AZ +27 more• Torn & Glasser, Inc.

Meritor Wabco Air Brake System (Meritor) – Incorrect Chamber Assembly (2021)

Meritor, Inc. (Meritor) is recalling certain TSE T2024 Air Chamber Part Number D3 3376T20. The spring brake chamber may have been assembled with incorrect springs that were out of specification, which can cause the pressure plate to shift.

NHTSAApr 8, 2021Nationwide• MERITOR WABCO

Ginseng Power 5000 (NSNY) – undeclared ingredients (2021)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

Class IHigh

FDAApr 8, 2021Nationwide• NSNY Distributor Inc

OrgaZEN 7000 (NSNY) – undeclared ingredients (2021)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

Class IHigh

FDAApr 8, 2021Nationwide• NSNY Distributor Inc

RayStation Software (RaySearch) – Dose Tracking Error (2021)

When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

FDAApr 7, 2021TN• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Calibration Serum Level 3 (Randox) – Bilirubin Bias (2021)

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

FDAMar 29, 2021CA, CT, IL +13 more• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland