Safety Recalls

15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 4,801–4,850 of 15,200

• Medical Device Recall · August 28, 2025

  Dexcom, Inc.

  Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description:

  A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

  Class I

• Drug Recall · August 28, 2025

  Granules Pharmaceuticals Inc.

  Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30

  Failed Impurities/Degradation Specifications:

  Class III

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Verio. Model Number: 10276755.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Howmedica Osteonics Corp.

  1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

  a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

  Class II

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Drug Recall · August 28, 2025

  Ascend Laboratories, LLC

  Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03

  Superpotent drug

  Class II

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Skyra fit. Model Number: 10849580.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Cima.X (DE). Model Number: 11647158.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Consumer Product Recall · August 28, 2025

  C.A.M.P. USA Inc., of Golden, Colorado

  Nimbus Lock Carabiners

  The carabiner's automatic closing mechanism can break and prevent the gate from closing, posing a risk of serious injury or death due to falling.

  Unclassified

• Consumer Product Recall · August 28, 2025

  Changzhou Hengze Home Furnishing Co., of China

  Lulive 12-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard required by the STURDY Act.

  Unclassified

• Consumer Product Recall · August 28, 2025

  DT Swiss, of Grand Junction, Colorado

  DT Swiss Carbon Fiber Road Wheels

  A defect in the wheel can compromise the wheel's structural integrity, posing a crash hazard.

  Unclassified

• Consumer Product Recall · August 28, 2025

  Air Vent Inc., of Dallas, Texas

  Electric motors for gable- and roof-mounted attic fans

  The recalled electric motor's safety cutoff may pose a risk of short circuit and fire hazard while in use.

  Unclassified

• Medical Device Recall · August 28, 2025

  Siemens Medical Solutions USA, Inc

  MAGNETOM Connectom.X. Model Number: 11371480.

  There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

  Class I

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Ber

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 070

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  1) Middlefield Original Cheese Co-op All Natural Mild Cheddar Cheese, 5 lb., packaged as individual loaves wrapped in plastic, packed 2 loaves per case (distribution) or 8 loaves per case (retail) 2)

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West S

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  Amerisource Health Services LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Do

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  1) Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced an

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  Zydus Pharmaceuticals (USA) Inc

  Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceutic

  Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  Middlefield Original Cheese Co-op Original Swiss Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged a

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC,

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz., packaged individually in plastic, packed 12 per case

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  1) Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles, Net Wt. 6 oz., packaged individually in plastic, packed 12 per case, UPC: 810665011156 2) Sunrise Creamery Dilly Pickle Jack M

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  Unichem Pharmaceuticals USA Inc.

  Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem

  Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

  Class I

• Drug Recall · August 27, 2025

  Atlantic Management Resources Ltd.

  Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01

  cGMP violations

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, D

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), a

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  Amerisource Health Services LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Indivi

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  1) Middlefield Original Cheese Co-op Monterey Jack, 5 lb., packaged as loaves wrapped in plastic and packed 8 loaves per case 2) Middlefield Original Cheese Co-op Provolone, 5 lb., packaged as loaves

  Potential contamination with Listeria monocytogenes

  Class I

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per case

  Potential contamination with Listeria monocytogenes

  Class I

• Drug Recall · August 27, 2025

  Amerisource Health Services LLC

  chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual

  Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Drug Recall · August 27, 2025

  DermaRite Industries, LLC

  McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.

  CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb., shredded in a plastic bag and packed 4 bags per case

  Potential contamination with Listeria monocytogenes

  Class I

• Medical Device Recall · August 27, 2025

  Vision RT Ltd

  The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

  Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

  Class II

• Food Recall · August 27, 2025

  Middlefield Original Cheese Cooperative

  Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lbs., packaged in a plastic bag, packed 4 bags per case

  Potential contamination with Listeria monocytogenes

  Class I