Safety Recalls

15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 6,801–6,850 of 15,271

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh & Ready Foods Roast Beef on Wheat Sandwich, 5oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89289 3

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh & Ready Foods Dark Wheat Sandwich, 7oz. plastic container. Best buy: 05/09/2025-05/12/2025 UPC# 6 82906 89057 4

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh Take Crave Away Turkey & Bacon Multigrain Sandwich; 6oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 8 06795 61438 1

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh & Ready Foods Italian Hoagie Sandwich; 6oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 6 82906 90114 0

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh Take Crave Away Chicken Salas Croissant; 6.5oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 8 06795 58553 7

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Food Recall · May 10, 2025

  Fresh & Ready Foods LLC

  Fresh Take Crave Away Italian Hoagie Sub Sandwich; 6oz PLASTIC CONTAINER; Best By: 05/09/2025 - 05/19/2025 UPC# 8 06795 61440 4

  Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

  Class I

• Medical Device Recall · May 9, 2025

  Baxter Healthcare Corporation

  2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600

  The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.

  Class II

• Medical Device Recall · May 9, 2025

  Ortho-Clinical Diagnostics, Inc.

  Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

  A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

  Class II

• Medical Device Recall · May 9, 2025

  Ortho-Clinical Diagnostics, Inc.

  Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions);

  a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

  Class II

• Drug Recall · May 9, 2025

  KVK Tech, Inc.

  Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

  cGMP deviations

  Class II

• Medical Device Recall · May 9, 2025

  Philips Respironics, Inc.

  BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.

  This device does not indicate for use in patients with respiratory failure.

  Class I

• Drug Recall · May 9, 2025

  KVK Tech, Inc.

  Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

  cGMP deviations

  Class II

• Food Recall · May 9, 2025

  Homegrown Family Foods LLC

  Shore Lunch BREADING & BATTER MIX OVEN STYLE A savory, crunchy coating perfect for fish, pork and chicken. Net Wt 6oz (170g) UPC 0 24739 12000 6 Summit Hill Foods Rome, GA 30162

  Undeclared Milk.

  Class I

• Medical Device Recall · May 9, 2025

  Ortho-Clinical Diagnostics, Inc.

  Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Produc

  a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

  Class II

• Food Recall · May 9, 2025

  BBF Massachusetts LLC

  Zeke's Daddy's Granola; INGREDIENTS: Whole grain rolled oats, maple syrup, expeller pressed canola oil, coconut, brown sugar, molasses, cinnamon, salt, natural flavor; Contains coconut; Manufactured i

  Product contains undeclared almond and cashew.

  Class I

• Food Recall · May 9, 2025

  Publix Super Markets, Inc.

  Greenwise Pear Kiwi Spinach & Pea Baby Food Pouch. Net Wt 4 oz. (113g). Stage 2 6 months+, Best if" date of 11/01/2025. Packed in 14 pouches per case, 4 oz per pouch. Distributed by Publix Super Marke

  Elevated levels of Lead, cadmium and arsenic

  Class II

• Medical Device Recall · May 9, 2025

  Barco N.V.

  Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H

  Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures

  Class II

• Vehicle Recall · May 9, 2025

  Honda (American Honda Motor Co.)

  2025 ACURA RDX

  A loss of power steering assist can require greater steering effort, increasing the risk of a crash or injury.

  Unclassified

• Vehicle Recall · May 9, 2025

  Honda (American Honda Motor Co.)

  2025 HONDA CRF1100

  The inability to use the horn or switch the headlight from low beam to high beam can increase the risk of a crash or injury.

  Unclassified

• Drug Recall · May 9, 2025

  AvKARE

  Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

  Failed Dissolution Specifications

  Class II

• Drug Recall · May 9, 2025

  Alembic Pharmaceuticals Limited

  Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceutical

  Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

  Class II

• Medical Device Recall · May 9, 2025

  Philips Respironics, Inc.

  BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

  This device does not indicate for use in patients with respiratory failure.

  Class I

• Medical Device Recall · May 9, 2025

  Philips Respironics, Inc.

  BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilat

  This device does not indicate for use in patients with respiratory failure.

  Class I

• Food Recall · May 8, 2025

  Bondsforever, Inc dba Shastha Foods

  Dixit Foods, Sabudana Khichadi, Net Wt. 200 g, Ingredients: Sago (Sabudana), Crushed Groundnuts, Sugar, DesiGhee, Salt, Green Chilli, Cumin Seeds. Allergen Information: May contain Peanuts, Treenuts,

  Undeclared allergens (milk and/or peanuts).

  Class II

• Medical Device Recall · May 8, 2025

  CareFusion 303, Inc.

  Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352]

  During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.

  Class II

• Consumer Product Recall · May 8, 2025

  Yamaha Corporation of America, of Buena Park, California

  YAMAHA PA-300C AC Power Adaptors

  The AC power adaptors can overheat and ignite, posing burn and fire hazards.

  Unclassified

• Food Recall · May 8, 2025

  Now Foods

  NOW Nutritional Yeast Powder, Nt. Wt. 10oz. UPC 7 33739 02460 2

  regular yeast was inadvertently packaged as nutritional yeast

  Class III

• Food Recall · May 8, 2025

  Bondsforever, Inc dba Shastha Foods

  Dixit Foods, Pohe, Net Wt. 110 g, Ingredients: Rice Flakes, Groundnuts, Edible Sunflower oil, Sugar, Salt, Green Chilli, Asafoetida, Curry Leaves, Mustard seeds, Turmeric Powder etc, Allergen Informat

  Undeclared allergens (milk and/or peanuts).

  Class II

• Vehicle Recall · May 8, 2025

  International Motors, LLC

  2024 INTERNATIONAL LT, 2025 INTERNATIONAL LT

  Brakes that are still engaged while driving increase the risk of crash.

  Unclassified

• Medical Device Recall · May 8, 2025

  BALT USA, LLC

  Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 008100685

  Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

  Class II

• Medical Device Recall · May 8, 2025

  CareFusion 303, Inc.

  BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES /

  Antivirus software was not consistently installed on impacted devices during the implementation process.

  Class II

• Consumer Product Recall · May 8, 2025

  Igloo Products Corp., of Katy, Texas

  Igloo 90 Qt. Flip & Tow Rolling Coolers

  The tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.

  Unclassified

• Medical Device Recall · May 8, 2025

  Ohio Medical Corporation

  GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

  Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

  Class II

• Medical Device Recall · May 8, 2025

  BALT USA, LLC

  Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES

  Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

  Class II

• Consumer Product Recall · May 8, 2025

  Taizhoushi Ermu Jinchukou Co., Ltd., dba Babywants, and owner of the Xylolin brand, of China

  Xylolin Peg Doll Toy Sets

  The peg dolls' spherical ends can block the child's airway, posing a risk of choking and death to children.

  Unclassified

• Consumer Product Recall · May 8, 2025

  Masco Canada Limited, of Canada

  Delta Gas Ball Valves

  Small amounts of gas can leak from the valve when it is in the open position, posing fire and burn hazards.

  Unclassified

• Consumer Product Recall · May 8, 2025

  DEMDACO, of Leawood, Kansas

  Maril Brand Scented Candles

  The candle's glass container can crack or break while the candle is burning, posing a laceration and fire hazard.

  Unclassified

• Consumer Product Recall · May 8, 2025

  deuter USA, of Longmont, Colorado

  Kid Comfort, Kid Comfort Pro and Kid Comfort Active Child Carriers

  The hinges on the foldable rear kickstand support leg can crack or break, posing a fall hazard.

  Unclassified

• Consumer Product Recall · May 8, 2025

  Legend Brands LLC, of New York

  Bliss Hair Dryers

  The handheld hair dryers lack an immersion protection device and can cause death or serious injury due to electrocution or shock if the hair dryers fall into water when plugged in. The hair dryers are in violation of federal regulations for hair dryers and present a substantial product hazard.

  Unclassified

• Consumer Product Recall · May 8, 2025

  Sanven Technology Ltd., of Rancho Cucamonga, California

  Stainless steel cable railing kits

  The bottom hole on the cable support posts is over four inches from the bottom of the base plate, posing an entrapment hazard to consumers.

  Unclassified

• Medical Device Recall · May 7, 2025

  Zyno Medical LLC

  Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

  Unreleased software versions were installed on distributed devices without verification or validation.

  Class I

• Medical Device Recall · May 7, 2025

  LUMITHERA INC

  Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration C

  U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

  Class III

• Medical Device Recall · May 7, 2025

  Beckman Coulter, Inc.

  DxI 9000 Access Immunoassay Analyzer C11137

  Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

  Class II

• Food Recall · May 7, 2025

  Vern's Foods & Farm

  Taylor Shellfish Farms Geoduck Chowder Base, frozen, Ingredients: Potatoes, Clam (Geoduck) ***Butter (Cream, Salt), Fish Sauce Ka Me***CONTAINS: MILK, CLAMS. Product is packed in rigid plastic tubs

  The ingredients statement declares fish sauce but does not declare anchovies. The Contains statement does not declare fish (anchovies).

  Class II

• Medical Device Recall · May 7, 2025

  Zyno Medical LLC

  Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

  Unreleased software versions were installed on distributed devices without verification or validation.

  Class I

• Medical Device Recall · May 7, 2025

  Zyno Medical LLC

  Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

  Unreleased software versions were installed on distributed devices without verification or validation.

  Class I

• Medical Device Recall · May 7, 2025

  Medtronic MiniMed, Inc.

  Medtronic, Simplera Sensor, REF: MMT-5100JD1

  The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

  Class II

• Medical Device Recall · May 7, 2025

  Zyno Medical LLC

  Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

  Unreleased software versions were installed on distributed devices without verification or validation.

  Class I

• Medical Device Recall · May 7, 2025

  Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

  Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/

  Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.

  Class II

• Drug Recall · May 7, 2025

  Alembic Pharmaceuticals Limited

  Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Guja

  Failed Impurities/Degradation Specifications

  Class II