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Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland Recalls

All product recalls associated with Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 2281–2300 of 25000 recalls

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

High

FDAMay 22, 2024Nationwide• Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland

Endo Model M Tibial Components (Waldemar Link) – Surgical Screw Issue (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

High

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Avalon Ultrasound Transducer (Philips) – Fetal Measurement Error (2024)

1...113 114115116 117...1250

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Potential for inaccurate fetal heart rate measurements when monitoring multiples.

High

FDAMay 22, 2024Nationwide• Philips North America Llc

Abbott Infinity 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

High

FDAMay 22, 2024Nationwide• Abbott Medical

Endo Model SL Tibial Components (Waldemar Link) – Surgical Screw Problem (2024)

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

High

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Moderate

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

DIAMOND COACH VIP (DIAMOND COACH) – Seat Mechanism Failure (2024)

Diamond Coach Corporation (Diamond Coach) is recalling certain 2023-2024 VIP 2200 transit buses, equipped with certain GO-ES Space Saver Foldaway Seats. The recliner mechanism may not engage when the seat back is fully reclined. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."

High

NHTSAMay 22, 2024Nationwide• DIAMOND COACH

Abbott Infinity 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

High

FDAMay 22, 2024Nationwide• Abbott Medical

IsoLoc Prostate Balloon (Angiodynamics) – Mislabeling Risk (2024)

A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).

Low

FDAMay 21, 2024Nationwide• Angiodynamics, Inc.

Acetaminophen Tablets (Contract Pharmacal) – Tablet Discoloration (2024)

Discoloration: Brownish tablets

Class IIModerate

FDAMay 20, 2024MI• Contract Pharmacal Corporation

Stimuplex A 30 DEG 20GX6 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Stimuplex A 30 DEG 21GX4 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Stimuplex A 30 DEG 24GX1 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Stimuplex A 30 DEG 22GX2 (B Braun) – DEHP Trace Glue (2024)

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Low

FDAMay 17, 2024Nationwide• B Braun Medical Inc

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

Class IIILow

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Plant-Rich Meal (Once Upon a Farm) – Listeria Risk (2024)

Listeria

Potential contamination with Listeria monocytogenes

Class IIModerate

FDAMay 17, 2024AL, FL, GA +7 more• ONCE UPON A FARM PBC

Super Lube Products (Kano Laboratories) – Poisoning Risk (2024)

Fire/Burn Risk

The recall involves Super Lube products which include the following: Syncopen Synthetic Penetrant, Fire Resistant Hydraulic Fluid, and Metal Protectant and Corrosion Inhibitor. The products are used to prevent corrosion in various machinery. Super Lube Syncopen Synthetic Penetrant was sold in a four-ounce white spray bottle (item number 85004), a 32-ounce or one-quart trigger spray black plastic bottle (item number 85032), and a one-gallon (item number 85010) white plastic bottle with a handle. The container bears the brand Super Lube followed by a flag of green, blue, orange, and yellow stripes. Super Lube Fire Resistant Hydraulic Fluid was sold in a one-gallon white plastic bottle (item number 86010) with a handle. Super Lube Metal Protectant & Corrosion Inhibitor was sold in a 32-ounce or one-quart trigger spray black plastic bottle with a handle (item numbers 83032 / 83032A). The Super Lube products have one of the following lot numbers located on the bottom or rear label: Super Lube Syncopen Synthetic Penetrant Size Item Number Lot Number 1.0 Gallon Bottle 85010 17348 L24 - 23320 K26 1.0 Quart Trigger Sprayer 85032 17290 J35 - 23320 K26 4 ounce Bottle 85004 17348 L24 - 23320 K26 Super Lube Fire Resistant Hydraulic Fluid Size Item Number Lot Number 1 Gallon Bottle 86010 16120 D48 - 24040 B16 Super Lube Metal Protectant & Corrosion Inhibitor Size Item Number 1 Quart Trigger Sprayer 83032 / 83032A 17348 L24 - 23297 J49

High

CPSCMay 16, 2024Nationwide• Kano Laboratories LLC, of Bohemia, New York

Abbott Proclaim Plus 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Proclaim XR 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical