Safety Recalls

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15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 12,001–12,050 of 15,364

Food Recall · May 14, 2024
H & U Inc. dba Sun Noodle
S&S Cup Saimin-Noodles with Soup & Garnish, NET WT. 5 oz., UPC 085315089056 and 085315089070
Undeclared egg
Class I
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Le
Lack of Assurance of Sterility
Class II
Drug Recall · May 14, 2024
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc.
Lack of Assurance of Sterility.
Class II
Drug Recall · May 14, 2024
Imprimis NJOF, LLC
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-
Lack of Assurance of Sterility
Class II
Medical Device Recall · May 14, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of tota
Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
Class III
Medical Device Recall · May 14, 2024
Greiner Bio-One North America, Inc.
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
Class II
Medical Device Recall · May 13, 2024
CareFusion 303, Inc.
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
Class II
Medical Device Recall · May 13, 2024
CareFusion 303, Inc.
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ 169-101, MEDBANK MINI 1HH-1HM-1FM/ 169-102, MEDBANK MINI 1HH-3HM/ 169-103, ME
Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.
Class II
Drug Recall · May 13, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 13, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Medical Device Recall · May 13, 2024
Aesculap Inc
Aeos Robotic Digital Microscope, Product Code: PV010
Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.
Class II
Drug Recall · May 13, 2024
American Regent, Inc.
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Subpotent product in addition to having out-of-specification results for impurities.
Class II
Drug Recall · May 13, 2024
Golden State Medical Supply Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Bar
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II
Medical Device Recall · May 13, 2024
SVS LLC
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Class II
Medical Device Recall · May 13, 2024
SIGHT DIAGNOSTICS LTD
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
Class II
Medical Device Recall · May 13, 2024
Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
Class II
Medical Device Recall · May 13, 2024
Young Dental Manufacturing I, LLC
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Class II
Medical Device Recall · May 13, 2024
Roche Diabetes Care, Inc.
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
Class II
Vehicle Recall · May 12, 2024
Toyota Motor Engineering & Manufacturing
2024 TOYOTA RAV4
A damaged brake line can cause a brake fluid leak, reducing brake performance and increasing the distance required to stop the vehicle. Wheel detachment can result in a loss of vehicle control. Either condition increases the risk of a crash.
Unclassified
Vehicle Recall · May 12, 2024
BMW of North America, LLC
2025 BMW X3
A loss of vehicle handling and control increases the risk of a crash.
Unclassified
Vehicle Recall · May 11, 2024
Nova Bus (US) Inc.
2023 NOVA BUS LFS
A seat belt that does not retract properly may result in a loose seat belt, which can increase the risk of injury in a crash.
Unclassified
Vehicle Recall · May 11, 2024
Lucid USA, Inc.
2024 LUCID AIR, 2025 LUCID AIR
A loss of power to the rear drive unit can result in a complete loss of drive power, increasing the risk of a crash.
Unclassified
Vehicle Recall · May 11, 2024
Tesla, Inc.
2024 TESLA CYBERTRUCK
A loss of drive power can increase the risk of a crash.
Unclassified
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class III
Medical Device Recall · May 10, 2024
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Class II
Food Recall · May 10, 2024
Healthwest Minerals, Inc. dba Mt. Capra Products
Mt. Capra Goat Milk Formula Recipe Kit (net wt. 10lbs. 8oz.) and Bundle Refill. Each Goat Milk Formula Recipe Kit consist of 10 individually packaged ingredients: *Whole Goat Milk *Goat Milk La
The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.
Class I
Medical Device Recall · May 10, 2024
Ethicon, Inc.
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 10, 2024
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled b
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III
Drug Recall · May 10, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactu
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III
Food Recall · May 10, 2024
Wehah Farms
Lundberg Family Farms Sustainable Wild Blend Gourmet Rice, 1 lb poly bag
Product may contain foreign object that appears to be of rodent origin.
Class II
Medical Device Recall · May 10, 2024
Ethicon, Inc.
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 M
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 10, 2024
Ethicon, Inc.
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 10, 2024
LEICA BIOSYSTEMS NUSSLOCH GMBH
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
Class II
Medical Device Recall · May 10, 2024
Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
Class II
Medical Device Recall · May 10, 2024
Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Class II
Drug Recall · May 10, 2024
Glenmark Pharmaceuticals Inc., USA
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II
Medical Device Recall · May 10, 2024
Beaver Visitec International, Inc.
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Class II
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabele
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III
Food Recall · May 10, 2024
Global Commodities Inc
Aahu Barah Apricot Roll; 14 oz; sold in clear plastic bags (6 inch x 8 inch) packing with the Aaha Barah label on the front and back; the product is labeled "Apricot Roll" on both the front and back;
Product contains elevated levels of undeclared sulfites.
Class I
Drug Recall · May 10, 2024
Bryant Ranch Prepack, Inc.
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III
Drug Recall · May 10, 2024
Preferred Pharmaceuticals, Inc.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Food Recall · May 10, 2024
Waco Bottling LLC
TriyBrewed Coffee Concentrate 6oz/177ml, amber glass bottle, 6pcs to case
No ingredient statement and no nutrition label
Class III
Food Recall · May 10, 2024
HP Hood (LAFARGEVILLE)
Price Chopper Fat Free Cottage Cheese with Pineapple Added 16oz plastic tub.
Contains undeclared sugar
Class II
Medical Device Recall · May 10, 2024
Ethicon, Inc.
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. The
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 10, 2024
Canon Medical System, USA, INC.
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
Class II
Medical Device Recall · May 10, 2024
Ethicon, Inc.
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are p
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 10, 2024
Ethicon, Inc.
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CO
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II
Medical Device Recall · May 9, 2024
Sol-Millennium Medical Inc.
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Lue
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Class II