Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,551–13,600 of 15,379
- Class II
Medical Device Recall · February 21, 2024
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.
- Class II
Medical Device Recall · February 21, 2024
Puritan Medical Products Company, Llc
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Sinus Compress (French), Item Number 24332FThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Back Wrap, Item Number 24312Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
MediBeads Neck Wrap, Item Number 34320Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Eye Compress, Item Number 2434Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class I
Medical Device Recall · February 21, 2024
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and componentsInfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Heating Pad, Item Number 24002Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Sinus Compress, Item Number 24332Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
Thermalon Neck Wrap, Item Number 24322Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class II
Medical Device Recall · February 21, 2024
Bruder Healthcare Company, LLC
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125RThermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
- Class I
Medical Device Recall · February 21, 2024
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and componentsInfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
- Class II
Medical Device Recall · February 21, 2024
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
- Unclassified
Consumer Product Recall · February 21, 2024
Toshiba Laptop AC AdaptersThe laptop AC adapters can overheat and spark, posing burn and fire hazards.
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Mung Bean Pineapple, 14oz (400g)Undeclared allergen; egg
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Mung Bean Pumpkin, 14 oz (400g)Undeclared allergen; egg
- Class II
Drug Recall · February 20, 2024
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class III
Medical Device Recall · February 20, 2024
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)Product was mislabeled as a Surgical Cap at its dispenser level.
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class II
Medical Device Recall · February 20, 2024
Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 7447Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
- Class I
Food Recall · February 20, 2024
BANH PIA Hopia Cake Mungbean Durian, 9.7oz (275g)Undeclared allergen; egg
- Class II
Drug Recall · February 20, 2024
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Class II
Medical Device Recall · February 20, 2024
3M Company - Health Care Business
3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 2Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.
- Class II
Medical Device Recall · February 20, 2024
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular systemBoston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
- Class II
Medical Device Recall · February 20, 2024
EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Class II
Medical Device Recall · February 20, 2024
EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPNInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Class I
Medical Device Recall · February 20, 2024
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
- Class III
Drug Recall · February 20, 2024
Contract Pharmaceuticals Limited Canada
Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- Class I
Food Recall · February 20, 2024
BANH PIA Hopia Cake, Mung Bean - Durian, 16.8 oz (480g)Undeclared allergen; egg
- Class II
Medical Device Recall · February 20, 2024
EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional meaInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Mungbean Durian, 14oz (400g)Undeclared allergen; egg
- Class I
- Class I
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Taro Durian, 14 oz (400g)Undeclared allergen; egg
- Class II
Drug Recall · February 20, 2024
Denver Solutions, LLC DBA Leiters Health
Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- Class II
Drug Recall · February 20, 2024
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01Failed Dissolution Specifications
- Class I
Food Recall · February 20, 2024
Banh Pia Classic Hopia, Mung Bean Durian, 16.8oz (480g)Undeclared allergen; egg
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Pandan Durian, 14oz (400g)Undeclared allergen; egg
- Class II
Medical Device Recall · February 20, 2024
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional meInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Black Sesame Durian, 14oz (400g)Undeclared allergen; egg
- Class I
Food Recall · February 20, 2024
Vegetarian Pia Cake Red Bean Durian, 14oz (400g)Undeclared allergen; egg
- Class II
Medical Device Recall · February 20, 2024
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional mInability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
- Class I
Medical Device Recall · February 19, 2024
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant KitObserved outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
- Class II
Drug Recall · February 19, 2024
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- Class II
Drug Recall · February 19, 2024
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.