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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 18081–18100 of 21320 recalls

Boston Scientific Corp: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 ...

The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.

FDAApr 30, 2008Nationwide• Boston Scientific Corp

Medtronic CardioVascular: AneuRx AAAdvantage stent graft and the Xcelerant Delivery...

Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.

FDAApr 29, 2008NC, VA• Medtronic CardioVascular

Siemens Healthcare Diagnostics, Inc.: Siemens Stratus CS Acute Care Troponin I CalPak. In vitr...

The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

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FDAApr 28, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

AGA Medical Corporation: AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. A...

AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devices to confirm the integrity of the ou

FDAApr 25, 2008AL, AZ, CA +17 more• AGA Medical Corporation

Becton Dickinson & Company: Ace Heat Therapy, A BD Product Up to 10 hours of Soothing...

Fire/Burn Risk

Potential for skin irritation and burns associated with the use of this product.

FDAApr 25, 2008Nationwide• Becton Dickinson & Company

AGA Medical Corporation: AGA Medical Corporation AMPLATZER Delivery System, 10 Fre...

FDAApr 25, 2008AL, AZ, CA +17 more• AGA Medical Corporation

Medtronic Neuromodulation: Suction Jar Lid for Medela Vario 18 Vacuum Pump used with...

The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.

FDAApr 25, 2008AR, CA, CT +12 more• Medtronic Neuromodulation

Biomet Sports Medicine: Artificial Ligament Fixation Device 15MM TI NS ToggleLoc ...

Six sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a suture that pulls the device through the tunnel. The hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. This may caus

FDAApr 24, 2008Nationwide• Biomet Sports Medicine

Ethicon Endo-Surgery Inc: ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized du...

The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

FDAApr 24, 2008PR• Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc: ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilize...

The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

FDAApr 24, 2008PR• Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc: ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload;...

The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

FDAApr 24, 2008PR• Ethicon Endo-Surgery Inc

Ethicon Endo-Surgery Inc: FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD0...

The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.

FDAApr 24, 2008PR• Ethicon Endo-Surgery Inc

Nerl Diagnostics LLC: S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bo...

Beverage may contain glass particles.

FDAApr 23, 2008Nationwide• Nerl Diagnostics LLC

Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: OMG (Observational Mechanical Gateway) Connector - A Mode...

The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.

FDAApr 22, 2008Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

Intuitive Surgical, Inc.: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Card...

The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.

FDAApr 18, 2008Nationwide• Intuitive Surgical, Inc.

Biomet Sports Medicine: BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number ...

This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1

FDAApr 17, 2008Nationwide• Biomet Sports Medicine

Biomet Sports Medicine: BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 90...

FDAApr 17, 2008Nationwide• Biomet Sports Medicine

Biomet Microfixation, Inc.: Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model num...

The working tips of the Stella Osteotomes are thicker than specification.

FDAApr 16, 2008MO, NM, TX• Biomet Microfixation, Inc.

OEC Medical Systems, Inc: OEC 9800 Image Intensified fluoroscopic x-ray system (inc...

Use of existing four-pedal footswitch on a different machine may cause various operational errors.

FDAApr 15, 2008Nationwide• OEC Medical Systems, Inc

Merit Medical Systems, Inc.: Custom Kit, REF: K05-00843, Revision L, Sterile, Merit M...

Convenience kits may be non-sterile due to inadequate package sealing.

FDAApr 15, 2008MO, OR• Merit Medical Systems, Inc.