Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,701–10,750 of 15,364
- Class II
Medical Device Recall · August 1, 2024
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictureWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictureWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused bWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class I
Medical Device Recall · August 1, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
- Unclassified
Consumer Product Recall · August 1, 2024
Avocado Mattress LLC, of Mexico
Avocado Organic Cotton Mattress Pad ProtectorsThe recalled mattress pads violate the mandatory federal flammability regulation for mattress pads, posing a fire hazard.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results foEscherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
- Class III
Drug Recall · August 1, 2024
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intriWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Food Recall · August 1, 2024
J-Basket Brand, Napa Kimchi, Net Wt. 14.1oz. plastic jar container (12 jars per case).High levels of Yeast growth and film on top of jarred Kimchi product.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictureWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures cauWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures causWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused byWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Class II
Medical Device Recall · August 1, 2024
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoWallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Unclassified
Consumer Product Recall · August 1, 2024
Zhongshanboshangkedianzishangwuyouxiangongsi, dba beberoadlove, of China
Beberoad New Moon Travel BassinetsThe recalled bassinets violate federal safety regulations for Infant Sleep Products because they do not have a stand, posing a fall hazard if used on elevated surfaces.
- Unclassified
Consumer Product Recall · August 1, 2024
ECHO Inc., of Lake Zurich, Illinois
ECHO gas-powered backpack blowersThe fuel supply line can leak gas, posing a fire hazard.
- Unclassified
Consumer Product Recall · August 1, 2024
Attom Tech. LLC, of Houston, Texas
LED Light-up Jelly Ring ToysThe recalled light-up jelly ring toys violate the mandatory federal battery-operated toy regulation because the rings contain button cell batteries that fit within CPSC's small parts cylinder, and can be easily accessed without requiring the use of a common household tool. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death, posing an ingestion hazard to children.
- Unclassified
Consumer Product Recall · August 1, 2024
Brompton Bicycle Inc., of Brooklyn, New York
Brompton T-Line Foldable BicyclesA loss of alignment between the handlebar and front wheel, due to insufficient torquing of steerer clamp bolts, can cause the rider to lose control of the steering, posing a fall hazard
- Unclassified
Consumer Product Recall · August 1, 2024
Shenzhen Two Pony Tech Co. Ltd., of China
Papablic Archie Infant SwingsThe swings pose a suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the federal safety regulations for Infant Sleep Products and the Safe Sleep for Babies Act. The swings also violate other requirements for infant swings and the labeling requirements for Reese's Law because the remote contains a button or coin-cell battery.
- Unclassified
Consumer Product Recall · August 1, 2024
RH US LLC, of Corte Madera, California
Jeune French Contemporary Upholstered Panel CribsThe cylindrical metal inserts in the crib's wooden frame can become loose and detach, posing a choking hazard.
- Class II
Medical Device Recall · July 31, 2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600During the manufacturing process the devices were laser-marked with the incorrect part number.
- Class I
Medical Device Recall · July 31, 2024
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMInsulin 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.
- Class I
Medical Device Recall · July 31, 2024
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMInsulin 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.
- Class I
Food Recall · July 31, 2024
Metro Produce Distributors, Inc.
Lunds & Byerlys Pico de Gallo / Guacamole Dip, Net Wt 18 oz (510g). UPC 0 72431-02993 6. Keep Refrigerated.Guacamole products may be contaminated with Listeria monocytogenes.
- Class II
Medical Device Recall · July 31, 2024
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
- Class II
Medical Device Recall · July 31, 2024
Stainless Steel Sims Uterine Sound, Part Number 64-601During the manufacturing process the devices were laser-marked with the incorrect part number.
- Class II
Drug Recall · July 31, 2024
Glenmark Pharmaceuticals Inc., USA
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals LimFailed Dissolution Specifications: below specification results
- Class I
Food Recall · July 31, 2024
Metro Produce Distributors, Inc.
Lunds & Byerlys Smokin' Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66130 3. Keep Refrigerated.Guacamole products may be contaminated with Listeria monocytogenes.
- Class I
Medical Device Recall · July 31, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851Insulin 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.
- Class II
Drug Recall · July 31, 2024
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Class I
Food Recall · July 31, 2024
Metro Produce Distributors, Inc.
Lunds & Byerlys Fresh Guacamole Dip, Net Wt 14 oz (396g). UPC 0 72431-66072 6. Keep Refrigerated.Guacamole products may be contaminated with Listeria monocytogenes.
- Class I
Food Recall · July 31, 2024
Metro Produce Distributors, Inc.
Lunds & Byerlys Deli Guacamole, Item 85999. Net Wt 56 oz. Keep Refrigerated.Guacamole products may be contaminated with Listeria monocytogenes.
- Class II
Medical Device Recall · July 31, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative dFirm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
- Class II
Medical Device Recall · July 31, 2024
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
- Class I
Food Recall · July 31, 2024
Metro Produce Distributors, Inc.
Lunds & Byerlys Spicy Guacamole Dip, Net Wt 10 oz (283g). UPC 0 72431-66128 0. Keep Refrigerated.Guacamole products may be contaminated with Listeria monocytogenes.
- Class II
Food Recall · July 30, 2024
Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Marcum brand ground cinnamon packaged in 1.5 oz clear plastic jarElevated lead levels in cinnamon
- Class II
Medical Device Recall · July 30, 2024
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;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.
- Class II
Food Recall · July 30, 2024
Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Restaurants- no label. Not individually packaged.Potential L. monocytogenes
- Class I
Food Recall · July 30, 2024
Boars Head Grab and Go Wedge Ham, Smoke Master Black Forest Ham, Grab and Go Sandwich, NET WT. 7.5 OZ (213 g), Plastic Container, KEEP REFRIGERATEDPotential Listeria Monocytogenes
- Class I
Food Recall · July 29, 2024
VEGAN OAT; Van Leeuwen PUMPKIN CINNAMON ROLL; NON-DAIRY FROZEN DESSERT 14 oz, (414 ml); Est. Brooklyn 2008 ingredients: oat milk (water, oats) coconut cream, cane sugar, brown sugar, unbleached wheatUndeclared peanuts (allergen)
- Class II
Medical Device Recall · July 29, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
- Class II
Food Recall · July 29, 2024
Item 71117.02008, Reser's American Classics Scalloped Potatoes, refrigerated product, net wt. 12oz. There are 6 packs per case.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.
- Class II
Food Recall · July 29, 2024
Item 71117.02126, Reser's American Classics Asiago Creamed Spinach, refrigerated product, net wt. 12oz. There are 6 packs per case.Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.