Safety Recalls
RSS ↗15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,301–5,350 of 15,259
- Class II
Drug Recall · July 30, 2025
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- Class II
Drug Recall · July 30, 2025
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Medical Device Recall · July 30, 2025
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM,Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SysBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SystBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class II
Medical Device Recall · July 29, 2025
Ortho-Clinical Diagnostics, Inc.
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SysBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class II
Drug Recall · July 29, 2025
Amerisource Health Services LLC
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Class II
Drug Recall · July 29, 2025
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.Subpotent drug
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SystBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SystBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class II
Medical Device Recall · July 29, 2025
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery SysBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class I
Medical Device Recall · July 29, 2025
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
- Class II
Medical Device Recall · July 28, 2025
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
- Class II
Medical Device Recall · July 28, 2025
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
- Class II
Medical Device Recall · July 28, 2025
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
- Class III
Food Recall · July 28, 2025
Anabolic Research WINN-50 (vanazolol). Dietary Supplement. 90 Capsules. UPC 8 51840-00707 6. Manafactured For: Anabolic Research, 6942 FM 1960 E. #346, Humble, TX 77346-2706.Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
- Class II
Medical Device Recall · July 28, 2025
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DIDue to a weld breakage between the pin and inserter holder of the Inserter Adapter.
- Class II
Food Recall · July 27, 2025
Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072Potential presence of glass pieces
- Class II
Food Recall · July 25, 2025
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Medical Device Recall · July 25, 2025
ZAP-X Radiosurgery System, Model: 300150If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.
- Class II
Drug Recall · July 25, 2025
Alembic Pharmaceuticals Limited
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., BCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Class II
Food Recall · July 25, 2025
La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Gelson's Hummus; Mediterranean Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10261Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
- Class I
Medical Device Recall · July 25, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4.Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
- Class II
Food Recall · July 25, 2025
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt California-Made; NET WT. 8OZ (226g) UPC: 23631-10268Gelson branded Tzatziki sauce product labels do not include storage instructions "keep refrigerated"
- Class II
Food Recall · July 25, 2025
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
La Michoacana Bubble Gum Single Serve Paleta 3.75oz UPC: 7-67778-00003-7Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Medical Device Recall · July 25, 2025
Olympus Corporation of the Americas
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utiPotential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
- Class I
Medical Device Recall · July 25, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4.Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
- Class II
Drug Recall · July 25, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent PhaCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Class II
Food Recall · July 25, 2025
La Michoacana Rompope Bolis 6-Count 24oz UPC:7-67778-05004-9Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"
- Class I
Food Recall · July 25, 2025
Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g) BANANA POUCHES 5-0.25 OZ (10g) APPLE POUCHES NET WT 5.6OZ (160g) NO ADDED SWEETENERS ONE INGREDIListeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
- Class II
Food Recall · July 25, 2025
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3Product label includes the ingredient CREAM but does not include Milk as the source.
- Class III
Medical Device Recall · July 25, 2025
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood forDue to incorrect/lack of Unique Device Identifier (UDI) codes.
- Class II
Food Recall · July 25, 2025
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0Product label includes the ingredient CREAM but does not include Milk as the source.
- Class II
Food Recall · July 25, 2025
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC:6-82082-61215-1Product label includes the ingredient CREAM but does not include Milk as the source.