Skip to main content

Is My Product Recalled?

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Scan How It Works Saved Get Alerts

Menu

Search All Recalls Latest Recalls Scan Barcode Get Alerts

Categories

Food Recalls Medication Recalls Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Resources

How Recalls Work FAQ Recall Classifications Statistics & Trends About

Your Recalls

Loading...

Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

Search Product Recalls

Try:····

Filters

Category

All Categories Food Medication Baby Products Pet Products Toys Electronics Household Vehicles Medical Devices Other

Time Period

All Time Last 30 Days Last 90 Days Last Year

State

Severity

All Severities Class I (High Risk)Class II (Moderate)Class III (Low)

Source

All Sources FDA CPSC USDA NHTSA

Status

Include terminated recalls

Clear all filters

Showing 4201–4220 of 11714 results

Sort:

Newest first Oldest first

WallFlex ESO Stent LL 18x103 (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 12.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Agile ESO OTW PC 23mm 15.0cm (Boston Scientific) – Catheter Tip Detachment (2024)

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

High

FDAAug 1, 2024Nationwide• Boston Scientific Corporation

Silver-Plated Copper Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

During the manufacturing process the devices were laser-marked with the incorrect part number.

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Stainless Steel Sims Uterine Sound (CooperSurgical) – Incorrect Part Number (2024)

During the manufacturing process the devices were laser-marked with the incorrect part number.

FDAJul 31, 2024Nationwide• CooperSurgical, Inc.

MiniMed 630G (Medtronic) – Physical Impact Damage (2024)

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Indomethacin Capsules (Glenmark) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: below specification results

Class IIModerate

FDAJul 31, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

MiniMed 670G (Medtronic) – Physical Impact Damage (2024)

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

MiniMed 620G (Medtronic) – Physical Impact Damage (2024)

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

FDAJul 31, 2024AL, AK, AZ +49 more• Medtronic MiniMed, Inc.

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

IMMAGE IGM Immunoglobulin M Reagent (Beckman Coulter) – Sensitivity Issue (2024)

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

FDAJul 31, 2024AZ, CA, CO +12 more• Beckman Coulter Inc.

Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

FDAJul 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

DR 800 X-ray System (Agfa) – Front Lever Chain Failure (2024)

Potential for the front lever chain of the DR 800 table to fail.

FDAJul 29, 2024Nationwide• Agfa N.V. Septestraat 27 Mortsel Belgium

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH UCFP (Siemens) – Quality Control Bias (2024)

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

FDAJul 29, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.

FDAJul 26, 2024Nationwide• Beaver Visitec International, Inc.

Arrow Arterial Kits and Trays as follows: (1) Arrow Arte... (ARROW INTERNATIONAL Inc.) – reports have been received regarding ... (2024)

Reports have been received regarding open seals on the packaging.

FDAJul 26, 2024Nationwide• ARROW INTERNATIONAL Inc.

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

FDAJul 26, 2024Nationwide• Carbon Medical Technologies, Inc.

1...209 210211212 213...586

Page 211 of 586Next