Safety Recalls

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

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Showing 9,301–9,350 of 15,362

Medical Device Recall · November 8, 2024
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Nu
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Food Recall · November 8, 2024
Wegmans Food Markets, Inc.
Wegmans Large Asian Sesame Salad with Chicken and Asian Peanut Dressing.
Contains undeclared egg
Class I
Medical Device Recall · November 8, 2024
O&M HALYARD, INC.
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK ,
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Drug Recall · November 8, 2024
ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road
Subpotent drug
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARY
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI S
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Beckman Coulter Inc.
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and
The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43;
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76L
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog N
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Numb
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:;
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLAS
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II
Medical Device Recall · November 8, 2024
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II
Medical Device Recall · November 7, 2024
Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Class II
Consumer Product Recall · November 7, 2024
Annex Products Pty Ltd., dba Quad Lock, of Australia
MAG Battery Packs
The battery pack in the chargers can overheat, posing a fire hazard.
Unclassified
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hights
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Consumer Product Recall · November 7, 2024
Guava Family Inc., of Solana Beach, California
Guava Roam Strollers
The stroller's brakes can fail to engage or unexpectedly disengage, posing fall and injury hazards to children.
Unclassified
Consumer Product Recall · November 7, 2024
DreamGro Enterprises LLC, of New York
Dreamgro Lullaby mermaid travel soothers
The recalled toy's gold-colored soft star can detach, posing a choking hazard to young children.
Unclassified
Drug Recall · November 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Failed Impurity/Degradation Specifications
Class II
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hight
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Drug Recall · November 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Failed Impurity/Degradation Specifications
Class II
Drug Recall · November 7, 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hight
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II
Consumer Product Recall · November 7, 2024
Govee Moments Trading Limited, of China and Govee Moments Limited, of China
GoveeLife and Govee Smart Electric Space Heaters
The smart electric space heaters can overheat, posing fire and burn hazards. Testing determined the smart electric space heaters do not comply with the voluntary industry safety standard, UL 1278, posing an overheating and fire risk from wireless control features.
Unclassified
Consumer Product Recall · November 7, 2024
Wolf Appliance Inc., of Madison, Wisconsin
Wolf Dual Fuel ranges with infrared griddles
The range can short-circuit if liquids boil over or are spilled and turn on the griddle unexpectedly, posing a burn and fire hazard.
Unclassified
Food Recall · November 7, 2024
Cumberland Packing Corp.
Organic Hot Agave in the Raw, 10 oz.
Elevated Osmophilic Yeast Count
Class II
Consumer Product Recall · November 7, 2024
Baofali Trading Co. Ltd., dba Unique Person Home Goods, of China
Baofali 4-in-1 Microfiber Crib Safety Bumpers
The recalled crib bumpers violate the federal crib bumper ban, posing a suffocation hazard to infants. Padded crib bumpers are banned by the federal Safe Sleep for Babies Act.
Unclassified
Consumer Product Recall · November 7, 2024
Kyte Baby, of South Lake, Texas
Kyte Baby Slumber Suits
The recalled slumber suits violate federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
Unclassified
Consumer Product Recall · November 7, 2024
Tala North America Inc., of New York
Tala Muse Portable Lamps
An electronic malfunction can cause the lamp's lightbulb to fail and the lithium battery to overheat, posing a fire hazard.
Unclassified
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II
Drug Recall · November 6, 2024
Midlab Incorporated
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II
Food Recall · November 6, 2024
Armonia Natural Store LLC
OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame
Class II
Medical Device Recall · November 6, 2024
Abbott Vascular Inc
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherect
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Class II
Medical Device Recall · November 6, 2024
Becton Dickinson & Co.
BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II
Medical Device Recall · November 6, 2024
Abbott Vascular Inc
20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Class II
Medical Device Recall · November 6, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II