Safety Recalls

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

Showing 8,451–8,500 of 15,362

• Medical Device Recall · January 13, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027

  Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

  Class II

• Medical Device Recall · January 13, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

  Possibility of the patient falling from the table related to the mattress used on the patient table.

  Class I

• Medical Device Recall · January 13, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

  Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

  Class II

• Medical Device Recall · January 13, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233

  Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

  Class II

• Medical Device Recall · January 13, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20 System Code: (1) 722038

  Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

  Class II

• Vehicle Recall · January 12, 2025

  Ford Motor Company

  2025 LINCOLN NAVIGATOR

  Inoperative or flickering reverse lights may not alert other drivers that the vehicle is reversing, increasing the risk of injury or crash.

  Unclassified

• Vehicle Recall · January 12, 2025

  Ford Motor Company

  2026 FORD MUSTANG

  An oil leak in the presence of an ignition source such as hot engine or exhaust components increases the risk of a fire. In addition, the loss of oil can result in engine seizure and loss of motive power, increasing the risk of a crash.

  Unclassified

• Vehicle Recall · January 12, 2025

  KTM North America, Inc.

  2024 HUSQVARNA SVARTPILEN 401, 2025 KTM 390 ADVENTURE R, 2025 KTM 390 ENDURO R

  A loss of drive power increases the risk of a crash or injury.

  Unclassified

• Vehicle Recall · January 12, 2025

  Ford Motor Company

  2025 FORD EXPEDITION, 2025 LINCOLN NAVIGATOR

  An unexpected loss of power brake assist while driving can extend stopping distance and increase the risk of a crash. Additionally, a loss of power brake assist while ADAS features are engaged can result in the vehicle not braking as expected, increasing the risk of a crash.

  Unclassified

• Vehicle Recall · January 12, 2025

  Chrysler (FCA US, LLC)

  2025 RAM 5500, 2025 RAM 3500, 2026 RAM 3500

  An instrument panel display that does not show critical information, such as warning lights or gear selection, increases the risk of a crash.

  Unclassified

• Medical Device Recall · January 10, 2025

  CareFusion 303, Inc.

  BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.

  Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

  Class II

• Medical Device Recall · January 10, 2025

  Fresenius Kabi USA, LLC

  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted r

  Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

  Class I

• Medical Device Recall · January 10, 2025

  Integra LifeSciences Corp.

  Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey i

  Potential that the induction seal is not completely sealed to the device tube packaging.

  Class II

• Drug Recall · January 10, 2025

  Teva Pharmaceuticals USA, Inc

  Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459

  Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

  Class II

• Food Recall · January 10, 2025

  Seoul Trading, Inc.

  Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. The label of recalled product declared: Ingredients: Cone sna

  Undeclared peanut.

  Class I

• Medical Device Recall · January 10, 2025

  Spectranetics Corporation

  Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; T

  Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

  Class I

• Vehicle Recall · January 10, 2025

  Tesla, Inc.

  2026 TESLA MODEL Y

  Reverse lights that fail to illuminate reduce visibility and may not alert pedestrians or other drivers that the vehicle is backing up, increasing the risk of a crash.

  Unclassified

• Medical Device Recall · January 10, 2025

  BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

  DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

  Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

  Class II

• Medical Device Recall · January 10, 2025

  Nobel Biocare

  . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an en

  Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

  Class II

• Vehicle Recall · January 10, 2025

  Toyota Motor Engineering & Manufacturing

  2025 TOYOTA TACOMA

  A broken driveshaft can impair steering. Vehicles with full-time 4WD may experience a vehicle rollaway while parked without the parking brake applied. Both scenarios increase the risk of a crash.

  Unclassified

• Vehicle Recall · January 10, 2025

  Toyota Motor Engineering & Manufacturing

  2023 TOYOTA TUNDRA, 2023 TOYOTA TUNDRA HYBRID, 2023 TOYOTA SEQUOIA HYBRID, 2024 TOYOTA TUNDRA, 2024 TOYOTA SEQUOIA HYBRID, 2024 TOYOTA TUNDRA HYBRID, 2025 TOYOTA SEQUOIA HYBRID, 2025 TOYOTA TUNDRA, 20

  A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.

  Unclassified

• Food Recall · January 9, 2025

  Global Commodities Inc

  AAHU BARAH brand SOFT PLUM; NET WT. 0.5 LB; Import By: AAHU BARAH USA, INC.; Soft Plum Aloo Bukahara 1/2 LB; *May Contain Sulfites As preservatives; UPC 882475049186; packaged in clear plastic bags.

  Product contains undeclared sulfites (4.66 mg/serving).

  Class II

• Medical Device Recall · January 9, 2025

  Kung Shin Plastics Co. Ltd.

  CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

  The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

  Class II

• Medical Device Recall · January 9, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813

  Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

  Class II

• Medical Device Recall · January 9, 2025

  Kung Shin Plastics Co. Ltd.

  CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

  The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

  Class II

• Medical Device Recall · January 9, 2025

  MEDLINE INDUSTRIES, LP - Northfield

  Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A

  Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

  Class II

• Medical Device Recall · January 9, 2025

  Medtronic Neuromodulation

  A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

  Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK

  Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

  Class II

• Medical Device Recall · January 8, 2025

  Ithera Medical Gmbh

  The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using c

  The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX

  Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

  Class II

• Consumer Product Recall · January 8, 2025

  Sig Sauer Inc., of Newington, New Hampshire

  SIG SAUER ROMEO5 Red Dot Sights

  The recalled firearm sights contain a button cell battery that violates the mandatory federal regulations for consumer products containing button cell batteries because the button cell batteries can be easily accessed, posing an ingestion hazard. The products include a button cell battery which is not in child-resistant packaging as required by Reese's Law. In addition, the products do not bear the required warnings. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death, posing an ingestion hazard to children.

  Unclassified

• Medical Device Recall · January 8, 2025

  Hologic, Inc.

  The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party sup

  Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

  Class II

• Medical Device Recall · January 8, 2025

  Stryker Corporation

  stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

  Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 20

  Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1F

  Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

  Class II

• Drug Recall · January 8, 2025

  Johnson, S C and Son, Inc

  babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC

  Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog

  Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

  Class II

• Medical Device Recall · January 8, 2025

  Stryker Corporation

  stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades

  Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

  Class II

• Medical Device Recall · January 8, 2025

  CareFusion 303, Inc.

  (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

  Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

  Class II

• Consumer Product Recall · January 8, 2025

  Shenzhenshimofanggekejiyouxiangongsi, of China

  Wemfg Children's Multi-Purpose Bike Helmets

  The helmets do not comply with the positional stability, impact labeling and certification requirements in violation of the CPSC federal safety regulation for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.

  Unclassified

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201867 JUST BAKED PUMPKIN CAKE MUNCHKINS 440x0.47 OZ, NET WT 12.93 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201817 APPLE FILLED PACZKI 66x4 OZ, NET WT 14.85 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201835 JUST BAKED YEAST MUNCHKINS 350x0.39 OZ, NET WT 8.49 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201845 GEN RG HEX DONUT DGH FRZ 144x1.88OZ, NET WT 15.23 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201806 RASPBERRY FILLED DONUT 78x2.75OZ, NET WT 12.07 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201870 GEN BAR FLUFF DONUT ZGT PFD 78x3OZ, NET WT 13.16 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201859 JUST BAKED CAKE RING 144x2.45 OZ, NET WT 22.05 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201864 JUST BAKED COFFEE ROLLS 78x3OZ, NET WT 14.62 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201872 BAV CRM BISMARK DONUT PFD 60x3.85OZ, NET WT 12.99 LB

  potential for contamination with listeria monocytogenes

  Class II

• Food Recall · January 7, 2025

  FGF, LLC

  item 8201922 FLAVORED RASPBERRY BISMARK PFD 3OZ, NET WT 13.16 LB

  potential for contamination with listeria monocytogenes

  Class II