Safety Recalls
RSS ↗15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,201–9,250 of 15,362
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) 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
Medical Device Recall · November 18, 2024
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change 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
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Organic Vegetable Medley; Broccoli, Carrots & Cauliflower. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78potential contamination with E. coli O121:H19
- Class I
Food Recall · November 18, 2024
4 Earth Farms formerly Mcl Fresh Inc
Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USApotential contamination with E. coli O121:H19
- 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 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 78716potential contamination with E. coli O121:H19
- Class I
Food Recall · November 18, 2024
WHOLE FOODS MARKET, Organic Carrots & Celery, 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
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a meThere is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.
- Class II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; 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 II
Medical Device Recall · November 18, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical 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
Food Recall · November 16, 2024
Grimmway Enterprises, Inc. dba Grimmway Farms
--- Organic Whole Carrots --- Organic Carrot 125/6 Cal-Organic Farms; Organic Carrot 150/5 Bunny Luv; Organic Carrots 10/5 Lb O-Organic; Organic Carrots 10/5 Simple Truth; Organic Carrots 10/5# 365 OPotential contamination with E. coli O121:H19
- Class I
Food Recall · November 16, 2024
Grimmway Enterprises, Inc. dba Grimmway Farms
--- Organic Baby Carrots --- Organic Baby Carrots 25 Grimmway Farms; Organic Baby Carrots 25 Lbs. Grimmway Farms --- Brand --- Grimmway FarmsPotential contamination with E. coli O121:H19
- Class I
Food Recall · November 16, 2024
Grimmway Enterprises, Inc. dba Grimmway Farms
--- Organic Whole Carrots --- Organic Clip Carrots 50 Lbs Cal-Organic Farm; Organic Clip Carrots 50 Lbs Cal-Organic RPC --- Brand --- Cal-OrganicPotential contamination with E. coli O121:H19
- Class I
Food Recall · November 16, 2024
Grimmway Enterprises, Inc. dba Grimmway Farms
--- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/12oz Steam-to-Serve; Organic Baby Peel Carrot12/12oz Steam-to-Serve RPC --- Brand --- Cal-Organic; MarketsidePotential contamination with E. coli O121:H19
- Class I
Food Recall · November 16, 2024
Grimmway Enterprises, Inc. dba Grimmway Farms
--- Organic Baby Carrots --- Orangic Baby Peeled Carrots 13/3 BL; Orangic Baby Peeled Carrots 30/1 BL; Org Baby Peeled Carrots 12/2 Wholesome Pantry RPC; Org Baby Peeled Carrots 24/1 Wholesome PantryPotential contamination with E. coli O121:H19
- Class II
Medical Device Recall · November 16, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming aThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class II
Medical Device Recall · November 15, 2024
mint Lesion, Software Versions: 3.10.0 and 3.10.1.Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
- Class II
Food Recall · November 15, 2024
7-Eleven Chicken Salad Sandwich, UPC 7 63913-79486 1. Net Wt. 7.0 oz (198g), Keep Refrigerated. Mfg By: Supermom's St. Paul Park, MN 55071Tuna salad sandwiches were labeled as chicken salad sandwiches.
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming anThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class II
Food Recall · November 15, 2024
Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per caseproduct may contain pieces of metal
- Class II
Medical Device Recall · November 15, 2024
mint Lesion, Software Versions: 3.9.0 through 3.9.5.Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming anThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or iThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class II
Drug Recall · November 15, 2024
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: LegacyPresence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable wThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class II
Food Recall · November 15, 2024
Impossible Savory Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02108 8; 8 retail chubs per caseproduct may contain pieces of metal
- Class II
Medical Device Recall · November 15, 2024
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation coThe warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Class I
Medical Device Recall · November 14, 2024
Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. FoPotential for the outer stainless-steel tube to break or detach.
- Unclassified
Consumer Product Recall · November 14, 2024
Home 4U, Inc., dba. Medical King, of Brooklyn, New York
Medical King Bed Assist Rail adult bed railsWhen the recalled bed rails are attached to an adult's bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
- Unclassified
Consumer Product Recall · November 14, 2024
Stokke LLC, of Stamford, Connecticut
YOYO³ strollersThe parking brake on the recalled strollers can disengage, posing an injury hazard.
- Class II
Drug Recall · November 14, 2024
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class I
Medical Device Recall · November 14, 2024
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and otPotential for the outer stainless-steel tube to break or detach.
- Class I
Medical Device Recall · November 14, 2024
Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissuPotential for the outer stainless-steel tube to break or detach.
- Class I
Medical Device Recall · November 14, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other sPotential for the outer stainless-steel tube to break or detach.
- Class II
Drug Recall · November 14, 2024
Amerisource Health Services LLC
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, InCGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Unclassified
Consumer Product Recall · November 14, 2024
Hallmark Cards, of Kansas City, Missouri
Hallmark Keepsake Christmas Tree Ornaments featuring the Cad Bane character from Star Wars: The Book of Boba FettThe brown paint on the exterior of the recalled Christmas tree ornaments did not fully dry before packaging, causing mold to grow on the exterior surface of the ornament, posing risk of respiratory issues to consumers due to mold exposure.
- Class II
Drug Recall · November 14, 2024
Amerisource Health Services LLC
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Class II
Drug Recall · November 14, 2024
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class I
Medical Device Recall · November 14, 2024
Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissPotential for the outer stainless-steel tube to break or detach.
- Class III
Drug Recall · November 14, 2024
Zydus Pharmaceuticals (USA) Inc
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USALabeling: Not Elsewhere Classified - Wrong NDC number
- Class II
Drug Recall · November 14, 2024
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, MadeCGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 370CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
- Class II
Drug Recall · November 14, 2024
Amerisource Health Services LLC
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
- Class II
Medical Device Recall · November 14, 2024
BD Pyxis CII Safe ES, REF: 1116-00Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- Class II
Medical Device Recall · November 14, 2024
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- Class II
Drug Recall · November 14, 2024
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.