Safety Recalls

15,768 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 251–300 of 15,768

• Medical Device Recall · July 1, 2026

  Aniara Diagnostica LLC

  5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

  Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

  Class II

• Food Recall · July 1, 2026

  Mellish Island Corp

  Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3

  Firm's finished product label does not declare the source of marine collagen which was determined to be fish.

  Class II

• Medical Device Recall · July 1, 2026

  Stryker GmbH

  Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.

  Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  Class II

• Medical Device Recall · July 1, 2026

  Stryker GmbH

  Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

  Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  Class II

• Medical Device Recall · July 1, 2026

  Biomet, Inc.

  Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

  Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

  Class II

• Medical Device Recall · June 30, 2026

  Medline Industries, LP

  Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

  Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

  Class II

• Medical Device Recall · June 30, 2026

  Medline Industries, LP

  Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN

  Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

  Class II

• Medical Device Recall · June 30, 2026

  Medline Industries, LP

  Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

  Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

  Class II

• Medical Device Recall · June 30, 2026

  Baxter Healthcare Corporation

  Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

  Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

  Class I

• Drug Recall · June 30, 2026

  Ascend Laboratories, LLC

  Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254

  Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

  Class III

• Medical Device Recall · June 30, 2026

  Boston Scientific Corporation

  Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.

  Potential for breach in sterile barrier of device packaging.

  Class II

• Medical Device Recall · June 30, 2026

  Merge Healthcare, Inc.

  Merge OrthoPACS, medical imaging diagnostic workstation

  Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

  Class II

• Medical Device Recall · June 30, 2026

  Boston Scientific Corporation

  Rapid Refill Continuous Injection System, UPN M00566001

  Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.

  Class II

• Drug Recall · June 30, 2026

  Ascend Laboratories, LLC

  Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255

  Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

  Class III

• Medical Device Recall · June 30, 2026

  Boston Scientific Corporation

  Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240

  Potential for breach in sterile barrier of device packaging.

  Class II

• Medical Device Recall · June 30, 2026

  Medline Industries, LP

  Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

  Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

  Class II

• Medical Device Recall · June 30, 2026

  KENT IMAGING, INC.

  SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

  The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

  Class II

• Medical Device Recall · June 30, 2026

  Merge Healthcare, Inc.

  Merge PACS, medical imaging diagnostic workstation

  Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

  Class II

• Medical Device Recall · June 30, 2026

  Boston Scientific Corporation

  Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC

  Potential for breach in sterile barrier of device packaging.

  Class II

• Drug Recall · June 29, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren

  cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

  Class II

• Medical Device Recall · June 29, 2026

  GE Medical Systems Information Technologies Inc

  GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

  Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

  Class II

• Medical Device Recall · June 29, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

  Firmware issue potentially leading to loss of geometry movements.

  Class II

• Drug Recall · June 29, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren

  cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

  Class II

• Drug Recall · June 29, 2026

  Cipla USA, Inc.

  Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren

  cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

  Class II

• Medical Device Recall · June 29, 2026

  Contego Medical, Inc

  Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-

  Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.

  Class II

• Medical Device Recall · June 26, 2026

  Siemens Healthcare Diagnostics, Inc.

  Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

  Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

  Class III

• Medical Device Recall · June 26, 2026

  Beckman Coulter Inc.

  REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B101

  Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

  Class II

• Medical Device Recall · June 26, 2026

  Galt Medical Corporation

  Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tub

  Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

  Class II

• Medical Device Recall · June 26, 2026

  Beckman Coulter Inc.

  REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Ins

  Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

  Class II

• Drug Recall · June 26, 2026

  Lannett Company Inc.

  Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Compa

  Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

  Class II

• Food Recall · June 26, 2026

  Total Nutrition Inc

  1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams

  Contaminated with Salmonella

  Class I

• Drug Recall · June 26, 2026

  Bionpharma Inc.

  Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

  Presence of Foreign Tablets/Capsules

  Class II

• Medical Device Recall · June 26, 2026

  Siemens Healthcare Diagnostics, Inc.

  Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL

  out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

  Class III

• Medical Device Recall · June 26, 2026

  Erbe USA Inc

  ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

  A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.

  Class II

• Consumer Product Recall · June 25, 2026

  Yongkang Ruihe Metal Products Co. Ltd., of China

  XW-A17 Electric Youth All-Terrain Vehicles (ATVs)

  The recalled youth ATVs violate the mandatory safety standard for ATVs because they are missing brake lights, reducing visibility of the youth ATV to other vehicles, posing a deadly crash hazard.

  Unclassified

• Drug Recall · June 25, 2026

  Bell Pharmaceuticals, Inc

  GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First A

  SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

  Class II

• Consumer Product Recall · June 25, 2026

  Lesonic Technology Co., Ltd., dba Small Fish, of China

  Small Fish Montessori Busy Board Toys

  The busy boards violate the mandatory safety standard for toys because magnets can detach, posing a deadly ingestion hazard. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.

  Unclassified

• Consumer Product Recall · June 25, 2026

  Daikin Comfort Technologies Manufacturing, Inc., of Houston, Texas

  Amana Window-Room-Air-Conditioners (WRAC) and Through the Wall (TTW) air conditioners or heat pumps

  The heating element can remain energized during a ground fault, despite being turned off, posing a risk of fire or burn injury to consumers.

  Unclassified

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 89

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Drug Recall · June 25, 2026

  Bell Pharmaceuticals, Inc

  Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

  SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

  Class II

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Compon

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Medical Device Recall · June 25, 2026

  ResMed Ltd.

  Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical vent

  Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

  Class I

• Drug Recall · June 25, 2026

  Bell Pharmaceuticals, Inc

  TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILL

  SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

  Class II

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Componen

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Contr

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Food Recall · June 25, 2026

  GELLERT GLOBAL GROUP

  Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea Spicy Tuna with Gochujang Kimbap, Keep Frozen-Do Not Th

  Undeclared Allergen (Fish)

  Class I

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI)

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Medical Device Recall · June 25, 2026

  Pride Mobility Products Corp.

  Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component:

  If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

  Class II

• Consumer Product Recall · June 25, 2026

  ABGA Advanced Trading Co., Ltd., of Walnut, California

  Honlyne LED Party Favors

  The LED party favors violate the mandatory safety standard for consumer products because the battery compartment within the light-up products contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

  Unclassified

• Consumer Product Recall · June 25, 2026

  Kith Retail Inc. of Brooklyn, New York

  Kids Kithmas Plaid Lounge Sets

  The recalled children's loungewear sets violate the mandatory flammability standards for children's sleepwear, posing a risk of serious burn injuries.

  Unclassified