Safety Recalls

15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 8,251–8,300 of 15,362

• Medical Device Recall · January 31, 2025

  Medtronic MiniMed, Inc.

  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751

  All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

  Class II

• Drug Recall · January 30, 2025

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Ro

  Failed Dissolution Specifications.

  Class II

• Consumer Product Recall · January 30, 2025

  Cabinet Health Inc., of Washington, D.C.

  Cabinet Health 4 oz. Refillable Medicine Bottles

  The plastic lid's closure can degrade after repeated openings, causing the lid's child-resistance to diminish, posing a risk of poisoning, if the contents are swallowed by young children.

  Unclassified

• Medical Device Recall · January 30, 2025

  Telcare, LLC

  Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

  Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.

  Class II

• Medical Device Recall · January 30, 2025

  LEICA BIOSYSTEMS NUSSLOCH GMBH

  Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

  Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

  Class II

• Consumer Product Recall · January 30, 2025

  AliExpress, of San Mateo, California

  6-in-1 Multi Styler and 5-in-1 Multi Styler Hair Dryers

  The handheld hair dryers lack an immersion protection device, posing an electrocution or shock hazard to consumers, if the hair dryers fall into water when plugged in. The CPSC has determined that hair dryers not equipped with the integral immersion protection present a substantial product hazard.

  Unclassified

• Consumer Product Recall · January 30, 2025

  Tupop E-Commerce Co. Ltd., of China

  Cozchique, Tebbis and Beeziac Girls Pajamas

  The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.

  Unclassified

• Medical Device Recall · January 30, 2025

  Micro Therapeutics, Inc.

  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-

  Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

  Class I

• Medical Device Recall · January 30, 2025

  Micro Therapeutics, Inc.

  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-

  Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

  Class I

• Consumer Product Recall · January 30, 2025

  AMX Global Inc., of Rochester Hills, Michigan

  AMX Global Portable Folding Stadium Seats

  The recalled stadium seats have bleacher security hooks that can crack and break, posing fall and injury hazards to consumers.

  Unclassified

• Consumer Product Recall · January 30, 2025

  Johnson Health Tech North America Inc. ("JHTNA"), of Cottage Grove, Wisconsin

  Matrix-brand Training Cycles

  The training cycles' adjustable seat can unexpectedly lower while in use, posing a fall hazard to the rider.

  Unclassified

• Consumer Product Recall · January 30, 2025

  Greater Goods LLC, of Saint Louis, Missouri

  Greater Goods Digital Kitchen Scales

  The recalled digital kitchen scales violate the mandatory federal regulations for consumer products containing button cell or coin batteries, because the scale has a lithium coin battery that can be easily accessed by children, and a spare coin battery provided with the product not in child resistant packaging, as required by Reese's Law. These violations pose an ingestion hazard. The recalled scales also do not have the required warnings. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.

  Unclassified

• Consumer Product Recall · January 30, 2025

  Pearhead, of Brooklyn, New York

  Pearhead Infant Learning Toy Sets

  Due to its size and shape, the wooden egg-shaped rattle in the recalled learning sets can get lodged in a child's throat, posing a choking hazard. This violates the federal regulations for infant rattles.

  Unclassified

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Medical Device Recall · January 29, 2025

  Pentax of America Inc

  PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL

  During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Medical Device Recall · January 29, 2025

  Stryker Corporation

  Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

  Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Drug Recall · January 29, 2025

  Glenmark Pharmaceuticals Inc., USA

  Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

  CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

  Class II

• Medical Device Recall · January 29, 2025

  Pentax of America Inc

  Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

  During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

  Class II

• Medical Device Recall · January 29, 2025

  Pentax of America Inc

  PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

  During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

  Class II

• Medical Device Recall · January 28, 2025

  GE Medical Systems, LLC

  Discovery XR656HD. X-Ray imaging system.

  The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

  Class II

• Medical Device Recall · January 28, 2025

  GE Medical Systems, LLC

  Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

  The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

  Class II

• Food Recall · January 28, 2025

  Trong Food International

  Madras Curry Powder sold in 3 different package sizes. Recall has been expanded to include ALL LOTS. CA RI NI AN DO "KIM TU THAP", NET WT./ Poids NET (4oz.) 114 grams glass jar UPC# 39606001562 (4oz

  Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.

  Class II

• Medical Device Recall · January 28, 2025

  GE Medical Systems, LLC

  Optima XR646 HD. X-Ray imaging system.

  The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

  Class II

• Drug Recall · January 28, 2025

  Ascent Consumer Products Inc.

  SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net

  Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

  Class I

• Drug Recall · January 28, 2025

  Ascent Consumer Products Inc.

  SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ

  Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

  Class I

• Drug Recall · January 28, 2025

  Ascent Consumer Products Inc.

  SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distri

  Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

  Class I

• Food Recall · January 28, 2025

  FRESHPOINT CENTRAL FLORIDA, INC.

  Garden Salad 5 oz Lot # 6620223 Best By: 02.05, UPC 766375733300

  Mislabeled salads (undeclared peanut allergen). Incorrect ingredient applied (peanuts)

  Class I

• Medical Device Recall · January 28, 2025

  GE Medical Systems, LLC

  Discovery XR656 HD. X-Ray imaging system.

  The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.

  Class II

• Medical Device Recall · January 27, 2025

  Merit Medical Systems, Inc.

  Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

  Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

  Class II

• Medical Device Recall · January 27, 2025

  Hiossen Inc.

  Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over

  Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

  Class II

• Medical Device Recall · January 27, 2025

  Dexcom, Inc.

  Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

  Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

  Class II

• Medical Device Recall · January 27, 2025

  Dexcom, Inc.

  Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

  Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

  Class II

• Medical Device Recall · January 27, 2025

  Dexcom, Inc.

  Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

  Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

  Class II

• Medical Device Recall · January 27, 2025

  TAS Medical Inc

  TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP

  Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent surgery to correct a large herniation.

  Class II

• Food Recall · January 27, 2025

  NEW YORK WHOLESALE GROUP

  ZAARAH HERBALS brand SHATAVARI POWDER; 100% ASPARAGUS RACEMOSUS; (Supports Female Reproductive System); Supreme Fine Powder 100g (3.5 oz); Manufactured by FALCON SYSTEM OF AYUREVEDIC PRODUCTS Auto Nag

  Product contains elevated levels of lead - 6.50 mg/kg (ppm)

  Class I

• Medical Device Recall · January 27, 2025

  Hiossen Inc.

  ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number:

  Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

  Class II

• Food Recall · January 27, 2025

  United Natural Trading Inc. dba Woodstock Farms

  Fresh Direct Dark Chocolate Pretzels 7oz, Bag. 12 bags per case.

  Undeclared Allergen - Milk

  Class I

• Medical Device Recall · January 27, 2025

  Hiossen Inc.

  Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over

  Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

  Class II