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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

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 32501–32520 of 37665 recalls

Boston Scientific Corporation: Excelsior SL-10 Microcatheter, placed in sterile pouch. ...

Packaging issue may result in failure to maintain sterile barrier.

FDAOct 7, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 c...

Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.

FDAOct 7, 2008Nationwide• Boston Scientific Corporation

Stelkast Co: Stelkast Dual Taper Wedge Pressed Fit Femoral Component. ...

Sterility may be compromised due to breach in packaging.

FDAOct 7, 2008

1...1624 162516261627 1628...1884

Page 1626 of 1884Next

IN, TX, WV

• Stelkast Co

Mindray DS USA, Inc., dba Datascope Patient Monitoring: AS3000 Anesthesia Delivery System. Datascope Patient Mon...

Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate

FDAOct 7, 2008CA, IN• Mindray DS USA, Inc., dba Datascope Patient Monitoring

Advanced Sterilization Products: STERRAD NX Sterilizer, Product Code 10033 Low temperatur...

ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.

FDAOct 7, 2008AL, AZ, CA +14 more• Advanced Sterilization Products

Integra LifeSciences Corp.: Gravity Compensating Accessory; High Pressure Range, Ster...

Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.

FDAOct 3, 2008CA, IL, IN +3 more• Integra LifeSciences Corp.

Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Ca...

Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

FDAOct 3, 2008Nationwide• Siemens Healthcare Diagnostics, Inc

Enterix, Inc.: INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, P...

False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.

FDAOct 3, 2008Nationwide• Enterix, Inc.

BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerab...

Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u

FDAOct 2, 2008CA, CT, FL +24 more• BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico

Varian Medical Systems Oncology Systems: Eclipse 8.5 (build 8.2.2X) systems with distributed Calcu...

When using the multiple static segment option, the device may alter dose delivery.

FDAOct 2, 2008Nationwide• Varian Medical Systems Oncology Systems

VIBE Technologies: Vibe Technologies, VIBE machine, Vibrational Integrated B...

Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.

FDAOct 1, 2008Nationwide• VIBE Technologies

Stryker Endoscopy: Stryker Endoscopy FloControl Arthroscopy Pump Integrated ...

Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.

FDAOct 1, 2008Nationwide• Stryker Endoscopy

VIBE Technologies: QuantumPulse machine. Vibe Technologies, Greeley, CO. T...

Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.

FDAOct 1, 2008Nationwide• VIBE Technologies

DeRoyal Industries Inc: DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. ...

Laceration Risk

Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.

FDAOct 1, 2008KY, LA• DeRoyal Industries Inc

DeRoyal Industries Inc: DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-ster...

Laceration Risk

Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.

FDAOct 1, 2008KY, LA• DeRoyal Industries Inc

Can-Am Youth ATVs (BRP) – Collision Risk (2008)

The recall involves Model Year 2008-2009 Can-Am® DS 90 X ATVs. The model name can be located on the side panels. The ATV is black with yellow and orange trim.

CPSCOct 1, 2008Nationwide• Vietnam Precision Industrial Co., of Vietnam

Philips Medical Systems North America Co. Phillips: Nuclear Magnetic Resonance Imaging System (MRI). Trace it...

Fire/Burn Risk

The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.

FDASep 30, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Varian Medical Systems, Inc.: GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, le...

Plastic needle tip could possibly crack or separate.

FDASep 30, 2008Nationwide• Varian Medical Systems, Inc.

Innovative Implant Technology: Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovat...

Laceration Risk

Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.

FDASep 30, 2008Nationwide• Innovative Implant Technology

Integra LifeSciences Corp: Uni-CP Compression Forceps (spreader); Non-sterile, R onl...

Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate

FDASep 30, 2008Nationwide• Integra LifeSciences Corp