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Boston Scientific Corp

Boston Scientific Corp Recalls

All product recalls associated with Boston Scientific Corp.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

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 17221–17240 of 21320 recalls

Boston Scientific Corp: Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm...

The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.

FDAJul 6, 2009Nationwide• Boston Scientific Corp

Philips Medical Systems North America Co. Phillips: Diagnost 96/97 DSI

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

FDAJul 6, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: EasyDiagnost

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

1...860 861862863 864...1066

Page 862 of 1066Next

FDA

Jul 6, 2009

Nationwide

• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: UroDiagnost

The x-ray system fail to meet the requirements of 21 CFR 1020.32(d)(2)(ii) when a specific tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch

FDAJul 6, 2009Nationwide• Philips Medical Systems North America Co. Phillips

Phillips Nuclear Medicine: BrightView Gamma Camera Radius Drive Assembly, manufactur...

Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

FDAJul 2, 2009Nationwide• Phillips Nuclear Medicine

Medtronic Neuromodulation: Medtronic SynchroMed II Programmable Pump, 8637, Rx Only,...

This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence

FDAJul 1, 2009DC, PR• Medtronic Neuromodulation

In-Wall Timers (Intermatic) – Shock Risk (2009)

This recall involves the Intermatic in-wall electronic timers with model numbers ST01, ST01C, ST01AC, ST01AC70, ST01C70, ST01CL, EI600C, EI600LAC, EI600LAC8, EI600WC, and EI600WC8. This product is a lamp and appliance timer and typically takes the place of a standard wall switch. The timer is white, off-white, or almond and measures 2 1/2 inches high by 1 3/4 inches wide. Model numbers can be found on the packaging and on the instruction. In-Wall timers are included in this recall if (1) the brand name "Intermatic" is molded on the front of the timer cover door, (2) the timer has only four keypad buttons, and (3) there is no 3-digit date code (e.g. "04C") stamped on the inside of the timer cover door. Timers with a 3-digit date code (e.g. "04C") stamped on the inside of the timer cover door are not included in this recall.

CPSCJul 1, 2009Nationwide• Intermatic Inc., of Spring Grove, Ill.

Siemens Medical Solutions USA, Inc: Koodinat M/MP Patient Table used with Angiostar Model 529...

The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.

FDAJul 1, 2009Nationwide• Siemens Medical Solutions USA, Inc

Boston Scientific Corporation: Boston Scientific (1) Flexima Regular Biliary Catheter ...

Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the

FDAJul 1, 2009Nationwide• Boston Scientific Corporation

Oridion Medical: Oridion Medical Capnostream20 capnograph/pulse oximeter m...

1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices

FDAJun 30, 2009Nationwide• Oridion Medical

Medtronic MiniMed: Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397...

Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.

FDAJun 29, 2009Nationwide• Medtronic MiniMed

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; L...

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6....

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Restoration Modular Conical Distal Bowed Stem. 14 mm x 19...

The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Restoration Modular Calcar Body, 19 mm +10 mm; Stryker O...

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Corin Unipolar Adapter Sleeve, For use with Corin Unipola...

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Restoration Modular hip System, Conical Distal Stem, 14 ...

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Restoration Modular Proximal Broached Body, Size 5; Stryk...

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm;...

Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

FDAJun 26, 2009Nationwide• Stryker Howmedica Osteonics Corp.

St. Jude Medical: SJM Peel Away Introducer, REF 405116, Lot 2694227, Length...

St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabelling to date.

FDAJun 24, 2009Nationwide• St. Jude Medical