Safety Recalls
RSS ↗17,567 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,951–6,000 of 17,567
- 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.
- Class II
Food Recall · September 18, 2025
Taproom Gourmet brand 20lb bulk "Park" MixNo ingredient label. Product contains undeclared allergens (peanuts, almonds, cashews, wheat, soy, and sesame)
- 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 II
Medical Device Recall · September 18, 2025
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq ASoftware issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- Unclassified
Vehicle Recall · September 18, 2025
2025 VOLVO VNL (4), 2026 VOLVO VNL (4)Trailer tail lights and turn signals that do not illuminate as intended can reduce visibility to other drivers, increasing the risk of a crash.
- Unclassified
Vehicle Recall · September 18, 2025
2026 VOLVO VNL (4)A door that cannot be opened from the inside may trap occupants, increasing the risk of injury.
- Class II
Medical Device Recall · September 18, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual LumenFirm 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
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
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETPotential 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.
- Class II
Medical Device Recall · September 18, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FFirm 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
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump"Firm 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
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFCPotential for the lid of the catheter connector to be in the incorrect position.
- 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
Food Recall · September 18, 2025
Taproom Gourmet brand 15lb bulk "Madison" MixNo ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
- Class II
Medical Device Recall · September 18, 2025
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound EPotential for the lid of the catheter connector to be in the incorrect position.
- 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.
- Unclassified
Consumer Product Recall · September 18, 2025
IcyBreeze Cooling LLC, of Grapevine, Texas
IcyBreeze Buddy Portable Misting FansThe misting fan can overheat while charging and ignite, posing a fire hazard.
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17Potential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04JDue to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
- 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
Food Recall · September 18, 2025
Taproom Gourmet brand 15lb bulk "Broadway" MixNo ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)
- 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.
- 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
PERIFIX FX Continuous Epidural Anesthesia Tray, 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: CE17TKFPotential for the lid of the catheter connector to be in the incorrect position.
- 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
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound EpidurPotential for the lid of the catheter connector to be in the incorrect position.
- 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
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
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.
- Unclassified
Consumer Product Recall · September 18, 2025
Yiwu Shi Yuxing Keji Youxiangongsi, dba YooxArmor, of China
YooxArmor Multi-Purpose Kids' HelmetsThe recalled kids' helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
- Class II
Medical Device Recall · September 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. ProPotential for the lid of the catheter connector to be in the incorrect position.
- Class II
Medical Device Recall · September 18, 2025
LOGIQ P10 series with software version R4.5.7 Model Number 5877534The 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 I
Food Recall · September 18, 2025
Western United Fish Company Inc
Kirkland Signature brand Ahi Tuna Wasabi Poke, Costco #17193, net wt. 1lb. Product is packaged in clear plastic clamshell container and sold to consumers.Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.
- 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
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 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
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 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
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
- Unclassified
Vehicle Recall · September 17, 2025
2025 BMW X1, 2025 BMW X2, 2025 MINI COUNTRYMAN S ALL4A damaged seat belt retractor may not properly restrain an occupant during a crash, increasing the risk of injury.
- 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
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
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
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 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.