Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesMedline convenience kits: PORT A CATH DYNJ906818A
Medline convenience kits: PORT A CATH DYNJ906818A
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
FDA DevicesDescription/REF: PARACENTESIS KIT/ASK-00376-JHH
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
FDA FoodFairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only
Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement
FDA DrugsAlyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
FDA DevicesiLet Bionic Pancreas, REF: BB1001
iLet Bionic Pancreas, REF: BB1001
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
FDA DevicesRitmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
FDA DevicesMedline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
FDA DevicesConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Potential for overpressure alerts.
FDA FoodAl Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
Product may be contaminated with Salmonella
NHTSAHyundai Motor America - Instrument Panel Display Failure/FMVSS 101
Hyundai Motor America - Instrument Panel Display Failure/FMVSS 101
An instrument panel display that fails to show critical safety information, such as the speedometer or warning lights, increases the risk of a crash.
FDA DrugsVistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
FDA FoodCANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)
CANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)
The product contains unapproved colors chlorophyll E140 and E141.
FDA DrugsMed Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
CGMP Deviations; deficiencies observed during FDA inspection
FDA DrugsLucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
CGMP Deviations; deficiencies observed during FDA inspection
NHTSAAirstream, Inc. - Printed Circuit Board May Overheat
Airstream, Inc. - Printed Circuit Board May Overheat
An overheated printed circuit board increases the risk of a fire.
NHTSAFord Motor Company - Vehicle Rollaway Risk
Ford Motor Company - Vehicle Rollaway Risk
Park system damage may result in a vehicle rollaway, increasing the risk of a crash.
NHTSAFord Motor Company - Fender Flare May Detach
Ford Motor Company - Fender Flare May Detach
A detached fender flare can become a road hazard and increase the risk of a crash.
FDA DevicesDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
FDA FoodSalt
Salt
Plain salt was labeled as iodized and iodized salt was labeled as plain.
FDA DrugsMed Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
CGMP Deviations; deficiencies observed during FDA inspection
NHTSAHarbinger Motors Inc. - Loose Steering Gear Mounting Bolts
Harbinger Motors Inc. - Loose Steering Gear Mounting Bolts
Broken or loose steering gear bolts can cause a loss of steering control, increasing the risk of a crash.
FDA DrugsQuala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Defective container:may contain bottles with incomplete seals
NHTSAElgin Sweeper Company - High Voltage Battery May Fail and Cause Fire
Elgin Sweeper Company - High Voltage Battery May Fail and Cause Fire
The defective batteries may overheat, increasing the risk of a fire.
FDA FoodWhite Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set. Contains: 3 popcorns & 3 popcorns seasonings. 2. Net Wt. 1.6 oz. (45g) UPC 7 36659-26501 8. Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold at West Allis Cheese and Sausage retail store. 3. Net Wt 0.7 oz (19g) Williams Sonoma, Not for Retail Sale. Sold in a Williams Sonoma branded Popcorn Sampler Gift Box. Set includes 2 popcorns, oil, seasoning and salt.
White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set. Contains: 3 popcorns & 3 popcorns seasonings. 2. Net Wt. 1.6 oz. (45g) UPC 7 36659-26501 8. Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold at West Allis Cheese and Sausage retail store. 3. Net Wt 0.7 oz (19g) Williams Sonoma, Not for Retail Sale. Sold in a Williams Sonoma branded Popcorn Sampler Gift Box. Set includes 2 popcorns, oil, seasoning and salt.
Products were made with recalled California Dairies milk powder due to Salmonella.