Safety Recalls
RSS ↗15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,151–9,200 of 15,362
- Class I
Medical Device Recall · November 20, 2024
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
- Class II
Food Recall · November 20, 2024
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's
Mama Mancini s Stuffed Shells with Sauce and Mozzarella Cheese, 4 packs of 4 lbs. each / 6 packs of 14 oz. each, 4 packs/boxes per case / 6 plastic trays per caseProducts have the potential to be contaminated with Listeria monocytogenes.
- Class II
Food Recall · November 20, 2024
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's
Hungryroot Ricotta Stuffed Shells, 6 packs of 14 oz. each, plastic traysProducts have the potential to be contaminated with Listeria monocytogenes.
- Class II
Food Recall · November 20, 2024
Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per caseUndeclared Yellow #5 and Yellow #6
- Class I
Medical Device Recall · November 20, 2024
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testingA software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
- Class II
Drug Recall · November 19, 2024
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Subpotent and Superpotent Drug
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Subpotent and Superpotent Drug
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505Subpotent and Superpotent Drug
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Subpotent and Superpotent Drug
- Class II
Medical Device Recall · November 19, 2024
Olympus Corporation of the Americas
Duravent Silicone Ventilation Tube. Model Number: 240075.Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Subpotent and Superpotent Drug
- Class II
Drug Recall · November 19, 2024
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265Subpotent and Superpotent Drug
- Class II
Medical Device Recall · November 19, 2024
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Class II
Drug Recall · November 19, 2024
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East BrunswicCGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Class II
Drug Recall · November 19, 2024
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma HoldCGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- Class II
Medical Device Recall · November 19, 2024
SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.Incomplete or partial pouch seals, which may result in a breach in the sterility.
- Class II
Medical Device Recall · November 19, 2024
VACUETTE SAFELINK, REF: 450210The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
- Class II
Medical Device Recall · November 19, 2024
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAXDevices were identified as released after repair without full testing being performed, which includes flow testing.
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation deviceComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- Class I
Drug Recall · November 18, 2024
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDLabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Class I
Drug Recall · November 18, 2024
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation deviceComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Stir Fry Medley; Carrots, Broccoli, Broccoli Stem, Stem. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 7871potential contamination with E. coli O121:H19
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Organic Vegetable Medley; Broccoli, Cauliflower, & Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: UNFI, Providence, RI 02908 USApotential contamination with E. coli O121:H19
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class I
Drug Recall · November 18, 2024
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977,Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation deviceComplaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
- Class I
Food Recall · November 18, 2024
WHOLE FOODS MARKET, Organic Carrot Sticks, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eatPotential contamination with E. coli O121:H19
- Class II
Medical Device Recall · November 18, 2024
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorgantSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class I
Food Recall · November 18, 2024
Fabalish Inc. , Kickin, Carrot Falafel , 10oz , Cardboard tray inside plastic film inside cardboard box, individual unitsPotential E Coli contamination.
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery trayCertain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
- Class I
Drug Recall · November 18, 2024
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Medical Device Recall · November 18, 2024
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Class II
Medical Device Recall · November 18, 2024
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 207Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716potential contamination with E. coli O121:H19
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorgantSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Organic Carrots. Bulk 1 pound bags. Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USApotential contamination with E. coli O121:H19
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorgantSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorganSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class II
Medical Device Recall · November 18, 2024
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISODue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
- Class II
Drug Recall · November 18, 2024
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. MorgantSuperpotent Drug and Subpotent Drug: potency failures obtained
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Organic Broccoli Slaw (Salade DE Brocoli), 4Earth Farms, Net Weight/Poids Net (340 g) 12oz (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Cpotential contamination with E. coli O121:H19
- Class II
Medical Device Recall · November 18, 2024
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEVDue to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.