Safety Recalls
RSS ↗15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,801–5,850 of 15,271
- Class II
Medical Device Recall · July 1, 2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULDevice used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
- Class II
Drug Recall · July 1, 2025
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los ALack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
- Unclassified
Vehicle Recall · July 1, 2025
2025 TESLA MODEL YA rearview camera that does not display an image reduces the driver's rear view, increasing the risk of a crash.
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: RobDue to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · July 1, 2025
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15508/25 Product Description:Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
- Class II
Medical Device Recall · June 30, 2025
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POCannulated fenestrated polyaxial screws may be incorrectly labeled
- Class II
Medical Device Recall · June 30, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Upgrade to MR 7700 Model Number (REF): 782130;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Intera 3.0T Quasar Dual Model Number (REF): 781150;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Drug Recall · June 30, 2025
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POCannulated fenestrated polyaxial screws may be incorrectly labeled
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model PURE 5000/10000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Drug Recall · June 30, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., BeCGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Class II
Medical Device Recall · June 30, 2025
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028.Potential for temporary loss of imaging (X-ray) functionality due to software issue.
- Class II
Medical Device Recall · June 30, 2025
SmartPath to dStream for 3.0T Model Number (REF): 782145;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Drug Recall · June 30, 2025
Dr. Reddy's Laboratories, Inc.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals HePresence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- Class II
Medical Device Recall · June 30, 2025
Ingenia 1.5T S Model Number (REF): 781347;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Medical Device Recall · June 30, 2025
Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class II
Medical Device Recall · June 30, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
- Class II
Medical Device Recall · June 30, 2025
Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class I
Medical Device Recall · June 30, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration.
- Class II
Medical Device Recall · June 30, 2025
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
- Class II
Medical Device Recall · June 30, 2025
Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Class I
Food Recall · June 29, 2025
Wiet Peeters Farm Products Limited
Aunt Mid's Fresh Sliced Mushrooms 227g (8 oz.) BEST BEFORE 25JL04 MEILLEUR AVANT, UPC 0 33383 676005 on top and best before date of BEST BEFORE 25JL04 stamped on side, 12 packages per casePotential to be contaminated with Listeria monocytogenes
- Class I
Food Recall · June 29, 2025
Wiet Peeters Farm Products Limited
Peeters Mushroom Farm Thick Slice Mushroom 10lb cardboard container labeled with Peeters Mushroom FarmPotential to be contaminated with Listeria monocytogenes
- Class I
Food Recall · June 29, 2025
Wiet Peeters Farm Products Limited
Peeters Mushroom Farm Cremini Sliced mushrooms 227g (8 oz.) UPC 0 68414 96960 3, flat black plastic package, BEST BEFORE 25JL04 stamped on side, 12 packages per casePotential to be contaminated with Listeria monocytogenes
- Class I
- Class I
- Class II
Medical Device Recall · June 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LKWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Class II
Food Recall · June 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG60002 Cucumber Mint Lemonade - point of service productThe firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Class II
Drug Recall · June 27, 2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Class I
Drug Recall · June 27, 2025
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- Class II
Food Recall · June 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG60007 Green Reviver Juice - point of service productThe firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
- Class III
Food Recall · June 27, 2025
Suspiros German Cake. 15 P: 37.5 servings (2062 gr), 4P: 10 servings (550gr). UPC= 15 P: 1342, 4P: 6971. Type of packaging: Plastic dome and plate (15P and 4P). Firm name: NOVACAB SAPI de CV. AddressMultiple cake products contain goat milk, which was labeled as "milk"
- Class III
Food Recall · June 27, 2025
Suspiros Tres Leches Cajeta Cake. 15 P: 25 servings (2500 gr), 4P: 7 servings (700gr), Pocket: 3.7 servings (370gr). UPC= 15P: 1335, 4P: 6982, POCKET: 35256. Type of packaging: Plastic dome and plateMultiple cake products contain goat milk, which was labeled as "milk"
- Class II
Food Recall · June 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG60005 Blueberry Basil LemonadeThe firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations