Safety Recalls
RSS ↗15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 4,351–4,400 of 15,200
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TPotential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux ValveFirm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Class I
Medical Device Recall · September 18, 2025
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W ZTA2-P-42-Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
- Class I
Food Recall · September 18, 2025
Sliced (1/4") green onions, refrigerated, packaged in plastic bag. Each case consist 5/6lbs. bag (net wt. 30lbs.). Garden Fresh Foods Inc. Woodinville, WA. Product is distributed in bulk package andPossible positive Listeria monocytogenes. Firm tested one lot of sliced green onions in-house and found Listeria monocytogenes.
- Unclassified
Consumer Product Recall · September 18, 2025
1616 Holdings Inc., of Philadelphia, Pennsylvania
Tabletop Fire PitsAlcohol fuel can splash or leak out of the fire pit reservoir during use and/or ignition, causing a flash fire that can spread and create larger hotter flames that can escape the unit, presenting risk of serious burn injury from flame jetting and fire hazards.
- Unclassified
Consumer Product Recall · September 18, 2025
Shenzhenshilongxingdashangmaoyouxiangongsi, dba LXDHSTRA, of China
LXDHSTRA Baby LoungersThe recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The sleeping pad is too thick, posing a suffocation hazard. The enclosed openings at the foot of the loungers are wider than allowed, posing a fall hazard and an entrapment hazard to infants. Also, the baby loungers do not have a stand, posing a fall hazard if it is used on elevated surfaces. These violations create an unsafe sleeping environment for infants and can cause death or serious injury to infants. In addition, the recalled baby loungers come with crib bumpers, which are banned by the Federal Safe Sleep for Babies Act because the padded crib bumpers can obstruct breathing, posing a risk of serious injury or death to infants from suffocation.
- Class II
Medical Device Recall · September 18, 2025
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE1Potential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
- Class II
Medical Device Recall · September 18, 2025
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19Potential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. ProPotential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
Fisher & Paykel Healthcare, Ltd.
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
- Class II
Medical Device Recall · September 18, 2025
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS.Potential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEMPotential for the lid of the catheter connector to be in the incorrect position.
- Unclassified
Consumer Product Recall · September 18, 2025
111495 Canada Inc., dba Arizer Tech, of Waterloo, Ontario
Arizer Solo II portable electronic vaporizer devicesThe internal lithium-ion battery can overheat, produce smoke, and/or eject material, posing fire and burn hazards.
- Unclassified
Consumer Product Recall · September 18, 2025
Changzhou Jiaxuan Intelligent Furniture Co. Ltd., of China
EnHomee 13-Drawer DressersThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers fail to meet the mandatory standard required by the STURDY Act.
- Unclassified
Consumer Product Recall · September 18, 2025
Wuensche USA, Chicago, Illinois
Ambiano Cotton Candy MakersThe heating element can cause sugar to ignite, if a consumer uses the product without the included sugar receptacle, posing a fire hazard.
- Unclassified
Consumer Product Recall · September 18, 2025
Shantou Xihong Technology Co. Ltd., of China
Youbeien Crib MobilesThe recalled toys violate the mandatory standard for toys containing button batteries because the compartment that holds the batteries in the remote can be accessed without the use of a common household tool. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns and death.
- Class I
Food Recall · September 17, 2025
Haifa COLD SMOKED SALMON 8 OZ.Contaminated with Listeria monocytogenes
- Class I
Food Recall · September 17, 2025
Haifa COLD SMOKED SEABASS 8 OZContaminated with Listeria monocytogenes
- Class II
Medical Device Recall · September 17, 2025
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
- Class II
Food Recall · September 17, 2025
Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "*** Lipton Green Tea Citrus (25g sugar)***" Individual bottle label reads as "*** Lipton Diet Green Tea MixedUndeclared sugar in finished product-primary package does not reflect the product inside bottle.
- Class II
Drug Recall · September 17, 2025
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.CGMP Deviations
- Class II
Medical Device Recall · September 17, 2025
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OSInstructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
- Class II
Medical Device Recall · September 17, 2025
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
- Class II
Medical Device Recall · September 17, 2025
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometersAffected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
- Class II
Drug Recall · September 17, 2025
Glenmark Pharmaceuticals Inc., USA
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USCGMP Deviations: Market complaints received for gritty texture (grainy)
- Class I
Medical Device Recall · September 17, 2025
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for UseIFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
- Class II
Medical Device Recall · September 17, 2025
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSureInSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- Class II
Medical Device Recall · September 16, 2025
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The SentineDue to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
- Class II
Medical Device Recall · September 16, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological systemA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class I
Drug Recall · September 16, 2025
IntegraDose Compounding Services LLC
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
- Class I
Medical Device Recall · September 16, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, PrPotential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
- Class II
Food Recall · September 16, 2025
Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. UPC: 011110624840Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Class II
Drug Recall · September 16, 2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, CampSubpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- Class II
Medical Device Recall · September 16, 2025
Medtronic Sofamor Danek USA Inc
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PLExpandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
- Class III
Food Recall · September 16, 2025
Gansu Zhaofeng Agricultural Development Co., Ltd.
G&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C was sterilized at high temperature PRODUCT OF CHINA U.S.A. DistUndeclared allergen (wheat).
- Class II
Medical Device Recall · September 16, 2025
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological systemA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Medical Device Recall · September 16, 2025
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological systemA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Food Recall · September 16, 2025
6+ Months SPROUT ORGANICS Made With Organic Sweet Potato, Apple & Spinach NET WT. 3.5 OZ (99g) INGREDIENTS: ORGANIC SWEET POTATOES, ORGANIC APPLES, ORGANIC SPINACH, WATER, ORGANIC LEMON JUICE. Dist. bPotential contamination with heavy metal (Lead).
- Class II
Food Recall · September 16, 2025
16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised Shrimp; 32oz clear plastic retail bag. UPC: 011110967015Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Class II
Medical Device Recall · September 16, 2025
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realityA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Medical Device Recall · September 16, 2025
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented realityA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Medical Device Recall · September 16, 2025
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological systemA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Medical Device Recall · September 16, 2025
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological systemA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
- Class II
Drug Recall · September 15, 2025
Graviti Pharmaceuticals Private Limited
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDCFailed Tablet/Capsule Specifications
- Class II
Medical Device Recall · September 15, 2025
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
- Class II
Food Recall · September 15, 2025
MIXED NUTS Roasted & Salted NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02236 1 DUndeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement
- Class II
Drug Recall · September 15, 2025
Amerisource Health Services LLC
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDCFailed Dissolution Specifications.