Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,401–13,450 of 15,379
- Class I
Medical Device Recall · March 1, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Class II
Medical Device Recall · March 1, 2024
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFEPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).Potential for positively biased results due to signal reduction over shelf life.
- Class II
Drug Recall · March 1, 2024
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.Failed Stability Specifications
- Class II
Medical Device Recall · March 1, 2024
Olympus Corporation of the Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640LDue to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- Class I
Medical Device Recall · March 1, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnlyPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face AAV Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Food Recall · March 1, 2024
KALO Carrot Cake All Natural Gluten Free Serving size one slice (6 oz/177g) CONTAINS MILK, EGG UPC 8 53407 00418 4 Distributed by: Kalo Foods, LLC Stokesdale, NC 27357The product is labeled as Carrot Cake on the top but the ingredient panel on the bottom is for Chocolate Cake. The Chocolate Cake ingredient statement does not include soy which is in the Carrot Cake.
- Class II
Medical Device Recall · March 1, 2024
25-LHP-928, HeNe Laser System, 25 mWThese laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary aPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renalPackaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- Class II
Medical Device Recall · March 1, 2024
MEDLINE INDUSTRIES, LP - Northfield
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience trayTrumpet Needle Guide ring can detach when excessive pressure is applied.
- Class I
Medical Device Recall · March 1, 2024
Mojo Non Vented Full Face Mask with Headgear, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Medical Device Recall · March 1, 2024
25-LHP-828, HeNe Laser System, 35 mWThese laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
- Class II
Medical Device Recall · March 1, 2024
Olympus Corporation of the Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645LDue to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- Class I
Medical Device Recall · March 1, 2024
Mojo 2 Full Face Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.Lack of Assurance of Sterility
- Class II
Medical Device Recall · February 29, 2024
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemicalProducts were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.Lack of Assurance of Sterility
- Class II
Medical Device Recall · February 29, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, oThe reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.
- Unclassified
Consumer Product Recall · February 29, 2024
Vernier Science Education, of Beaverton, Oregon
Vernier Go Direct® Charge StationsThe recalled charge station can overheat, posing a burn hazard to consumers.
- Class II
Medical Device Recall · February 29, 2024
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemicalEsculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected . Esculin is expected to trigger this fluorescence and test cancellation.
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.Lack of Assurance of Sterility
- Class II
Food Recall · February 29, 2024
Vitony Bakery, Bizcocho de Queso (cheesecake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)Undeclared allergens FD&C Yellow #5, Yellow #6
- Class II
Food Recall · February 29, 2024
Vitony Bakery, Bizcocho de Queso y Guayaba (cheese-guava cake), PESO NETO 14oz (397g) (12 (14 oz) packages per case)Undeclared allergens FD&C Yellow #5, Yellow #6
- Class II
Drug Recall · February 29, 2024
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility,Lack of Assurance of Sterility: Firm did not perform process validation.
- Unclassified
Consumer Product Recall · February 29, 2024
The Home Appliances Inc., d/b/a Camplux, of North Charleston, South Carolina
Camplux portable tankless water heatersThe portable water heaters can leak gas from the gas regulator connection, posing a fire hazard.
- Class II
Drug Recall · February 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing FLack of Assurance of Sterility: Firm did not perform process validation.
- Class II
Drug Recall · February 29, 2024
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.Lack of Assurance of Sterility
- Class II
Food Recall · February 29, 2024
AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT. 250ml. Packaged in a LDPE bottle. Refrigerate after opening.Potential contamination with Clostridium botulinum
- Class II
Drug Recall · February 29, 2024
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.Lack of Assurance of Sterility
- Class II
Drug Recall · February 29, 2024
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.Lack of Assurance of Sterility
- Unclassified
Consumer Product Recall · February 29, 2024
Cycling Sports Group Inc., dba Cannondale, of Wilton, Connecticut
2021 through 2023 Model Year Cannondale Dave bicyclesThe bicycle headtube/downtube weld can become damaged, and separate from the bicycle frame, posing fall and injury hazards.
- Unclassified
Consumer Product Recall · February 29, 2024
SMART Technologies ULC, of Canada
Electric Height-Adjustable Mobile Stands for Large Interactive Flat Panel DisplaysThe wheelbase welds on the stands can bend or break while the stand is being moved, causing the stands to fall over, posing tip-over and entrapment hazards.
- Unclassified
Consumer Product Recall · February 29, 2024
Oso Children LLC, of San Francisco, California
Children's Pajama SetsThe recalled children's pajama sets violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- Unclassified
Consumer Product Recall · February 29, 2024
Bombardier Recreational Products Inc., of Canada
Ski-Doo® MXZ and Renegade Snowmobiles equipped with Pilot X SkisThe snowmobile's left ski can break, posing a risk of serious injury and crash hazard.
- Unclassified
Consumer Product Recall · February 29, 2024
Liverpool Football Club, of United Kingdom (UK)
Liverpool Football Club (L.F.C.) Children's PajamasThe recalled children's pajamas fail to meet the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- Unclassified
Consumer Product Recall · February 29, 2024
Nutraceutical Corporation, of Salt Lake City, Utah
Heritage Store Hydrogen Peroxide MouthwashThe recalled mouthwash contains ethanol in a concentration which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- Unclassified
Consumer Product Recall · February 29, 2024
Garden Games Ltd, of United Kingdom
Sandford Family 6-Player Croquet SetsThe paint or surface coating on the red mallet, blue mallet, red hoop, and winning post contain levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard. In addition, the coating on the red and blue mallets contains levels of regulated phthalates that exceed the prohibition of specific phthalates. Lead and phthalates are toxic if ingested by young children and can cause adverse health issues.
- Unclassified
Consumer Product Recall · February 29, 2024
Premier P. LTD, of United Kingdom
Vanilla Underground "Minecraft TNT" One-Piece PajamasThe recalled children's pajamas fail to meet the federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Class II
Medical Device Recall · February 28, 2024
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Class II
Medical Device Recall · February 28, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device.