Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,501–9,550 of 15,364
- Class II
Medical Device Recall · October 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JPSmiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Class II
Medical Device Recall · October 28, 2024
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increase the chance of injury to the tissues of the lung as the scope is withdrawn including the possibility of pneumothorax.
- Class II
Medical Device Recall · October 28, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JPSmiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Class II
Medical Device Recall · October 28, 2024
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
- Class II
Medical Device Recall · October 28, 2024
Discovery MR750w 3.0T, whole body magnetic resonance scannerGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 28, 2024
SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemGradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Class II
Medical Device Recall · October 25, 2024
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
- Class II
Medical Device Recall · October 25, 2024
Galaxy System (GAL-001)Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.
- Class II
Food Recall · October 25, 2024
BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASEProduct contains undeclared sulfites. The product was sampled by the NYSAGM s Food Safety Division and tested positive at 120.7 PPM Sulfites.
- Class II
Drug Recall · October 25, 2024
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- Class I
Food Recall · October 25, 2024
Grand Central Bakery FRE Co Inc
U-BAKE Marionberry Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 4oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.Undeclared egg
- Class II
Medical Device Recall · October 25, 2024
MEDLINE INDUSTRIES, LP - Northfield
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
- Class I
Food Recall · October 25, 2024
Grand Central Bakery FRE Co Inc
U-BAKE Chicken Pot Pie, frozen product and packaged in heat-sealable polypropylene film. Net wt. 11.5oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.Undeclared egg
- Class I
Food Recall · October 25, 2024
Grand Central Bakery FRE Co Inc
U-BAKE Apple Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 9oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.Undeclared egg
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1cGMP Deviations
- Unclassified
Consumer Product Recall · October 24, 2024
Jiangsu Tiking Sports Vehicle Manufacturing Co. Ltd., of China (youth ATV)
Ricky Powersports Tumble Weed Youth and TGB Blade Adult All-Terrain Vehicles (ATVs)The recalled ATVs fail to comply with the requirements of the federal mandatory ATV safety regulations. The youth ATVs' mechanical suspension fails to comply with safety requirements, posing a crash hazard. The adult ATVs' service brakes fail to sufficiently stop the vehicle, posing a crash hazard, and the handlebars pose a laceration hazard if the adult rider's body or head impacts the handlebars. ATVs that fail to meet the mandatory safety regulations pose a risk of serious injury or death.
- Class II
Medical Device Recall · October 24, 2024
GE Healthcare (China) Co., Ltd.
GE Proteus XR/A radiographic systemSteel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5cGMP Deviations
- Class II
Drug Recall · October 24, 2024
Unexo Life Sciences Private Limited
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9cGMP Deviations
- Unclassified
Consumer Product Recall · October 24, 2024
PowerBlock Inc., Burnsville, Minnesota
Commercial Pro 100 sold with 5 lb grip handlesWeight plates above 55 lbs included in the set can dislodge from the 5 lb grip handles, posing an impact injury hazard to the user.
- Unclassified
Consumer Product Recall · October 24, 2024
CFMOTO Powersports Inc., of Plymouth, Minnesota
2024 CFORCE 800 Touring and 2024 CFORCE 1000 Touring All-Terrain Vehicles (ATVs)The throttle lever on the recalled ATVs can fail to return to the idle position when a driver releases it, and the vehicle could then unexpectedly continue to accelerate, posing a crash hazard.
- Class II
Drug Recall · October 23, 2024
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
UA KIT, SKU DYKM1690A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
Lab Kit, SKU DYLAB1018; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV19During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Drug Recall · October 23, 2024
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltimorCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Class II
Medical Device Recall · October 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
URINE KIT, SKU DYKM1845; Component No. 503581Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Class II
Medical Device Recall · October 23, 2024
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal DialysisThere has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Class II
Food Recall · October 23, 2024
Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: JUndeclared wheat. Product contains wheat but was mis-labeled as Savory 6 Cut Crinkle Cut Wedge and label does not declare wheat.