Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

5876–5900 of 52958

HighFDA (Devices)·Z-0779-2025·2025-01-08
Medline Surgical Procedure Kits Recalled for Non-Sterile Components
Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.
Product
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0322-2025·2025-01-08
King Kullen and Wild by Nature vegetable platters recalled for Listeria
Gracie's Kitchens Inc. is recalling King Kullen and Wild by Nature brand vegetable platters (44 oz) distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates from November 14-24, 2024.
Product
a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10005; 44 oz plastic container
Category
Food
Distribution
2 states
HighFDA (Food)·F-0340-2025·2025-01-08
Gracie's Kitchens Mango Berry Products Recalled for Listeria Risk
Mango Berry smoothies sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands may be contaminated with Listeria monocytogenes. Affected products have Sell By dates between 11/11/24 and 11/21/24.
Product
a.) King Kullen brand Mango Berry; UPC: 85316-10378; 12 oz plastic container b.) Wild By Nature brand Mango Berry; UPC: 85316-10378; 12 oz plastic container c.) Gracie's Kitchen brand Mango Berry; UPC: 85316-10325; 12 oz plastic container d.) Gracie's Kitchen brand Mango Berry Cu
Category
Food
Distribution
2 states
HighFDA (Food)·F-0339-2025·2025-01-08
Mango Products Recalled for Potential Listeria Contamination
Multiple mango brands sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to retailers.
Product
a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plastic container c.) Wild by Nature brand Mango; UPC: 85316-10377; 12 oz plastic container d.) Gracie's Kitchen brand Mango Spears; UPC: 85316-10337
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0789-2025·2025-01-08
Medline MICRODISECTOMY PACK recalled for endotoxin contamination
Medline custom MICRODISECTOMY PACK kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination are being recalled. Approximately 1,494 units were distributed in the US, UAE, and Canada.
Product
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V002000·2025-01-06
Tesla Model X, Model Y, Model S, and Model 3 Rearview Camera Loss
Tesla is recalling certain 2023–2025 Model X, Model Y, Model S, and Model 3 vehicles because the computer circuit board may short, disabling the rearview camera image. This reduces rear visibility and increases crash risk.
Product
TESLA — TESLA MODEL Y, MODEL X, MODEL S, MODEL 3
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-01052025-01·2025-01-05
Frozen Raw Ground Beef Recalled for Foreign Matter Contamination
USDA FSIS issued a public health alert for frozen raw ground beef from Stockyards Packing Co. due to possible hard plastic and metal contamination.
Product
Stockyards Packing Co LLC — FSIS Issues Public Health Alert for Frozen, Raw Ground Beef Products Due to Possible Foreign Matter Contamination
Category
Food
Distribution
1 state
HighCPSC·25082·2025-01-02
Yaomiao Children's Jewelry Sets Recalled for Dangerous Lead and Cadmium Levels
Yaomiao children's jewelry sets sold on Amazon contain dangerous levels of lead and cadmium. Consumers should stop using them immediately, keep them away from children, and request a refund from the seller.
Product
Yaomiao Children's Jewelry Sets
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·25081·2025-01-02
Euqee Wintergreen Essential Oil Recalled for Unsafe Packaging
Euqee Wintergreen Essential Oils sold on Amazon.com are recalled because their packaging is not child-resistant, violating federal law. Methyl salicylate in the oil could poison young children if swallowed.
Product
Euqee Wintergreen Essential Oils
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V001000·2025-01-02
Aston Martin Vehicles Recalled: Infotainment Display Obstructs Rearview Camera
Aston Martin is recalling certain 2024-2025 DB12, Vantage, and DBX707 vehicles. The infotainment home screen menu may obstruct the rearview camera when in reverse, reducing rear visibility and increasing the risk of a crash.
Product
ASTON MARTIN — ASTON MARTIN VANTAGE, DBX707, DB12
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·25083·2025-01-02
John Deere ZTrak Zero-Turn Mowers Recalled for Fire and Burn Hazards
Kawasaki is recalling about 39,000 John Deere ZTrak zero-turn mowers with Kawasaki engines because the voltage regulator can fail, causing the engine to overheat and creating fire and burn hazards. No injuries have been reported to date.
Product
John Deere ZTrak™ Zero Turn Mowers with Kawasaki Engines
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0731-2025·2025-01-01
Abbott Vascular inflation device may leak during cardiovascular procedures
Abbott Vascular is recalling 20/30 Priority Pack Accessory Kit inflation devices due to potential leaks that could cause air embolism during cardiovascular procedures.
Product
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Category
Medical Device
Distribution
40 states
HighFDA (Drugs)·D-0165-2025·2025-01-01
Duloxetine delayed-release capsules recalled due to manufacturing impurity
Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).
Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0751-2025·2025-01-01
Daytona Small Stature Locking Caps recalled for manufacturing defects
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Product
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0736-2025·2025-01-01
Siemens epoc Blood Analysis System Recalled for Patient Identification Software Error
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Product
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0694-2025·2025-01-01
Panther Fusion Assay Kit Recalled for Possible SARS-CoV-2 False Positives
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
Product
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0157-2025·2025-01-01
Duloxetine Delayed-Release 60 mg Capsules Recalled for N-Nitroso Impurity
Amerisource Health Services is recalling Duloxetine Delayed-Release Capsules 60 mg due to N-nitroso impurity levels exceeding FDA recommended limits. The recall affects 20,734 bottles distributed nationwide.
Product
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0158-2025·2025-01-01
Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0160-2025·2025-01-01
Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0159-2025·2025-01-01
Prescription chlorpromazine tablets recalled due to manufacturing quality defect
Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2025·2025-01-01
Surgical Patties and Strips with Endotoxin Contamination in Medline Convenience Kits
Medline Industries is recalling surgical patties and strips in specific lots of KIT,SPINE LH Convenience Kits due to higher-than-expected endotoxin levels in raw materials. The contamination may result in out-of-specification endotoxin in finished sterile products.
Product
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0164-2025·2025-01-01
Diagnostic drug kit recalled due to sterility concerns and vial integrity issues
Curium US is recalling Technetium TC 99m Sestamibi diagnostic kits (Lot 092-24006) due to improper vial crimps that could compromise sterility assurance. The recall affects approximately 5,160 vials distributed nationwide.
Product
TECHNETIUM TC 99M SESTAMIBI — TECHNETIUM TC 99M SESTAMIBI (TECHNETIUM TC 99M SESTAMIBI)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2025·2025-01-01
Medline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
Medline is recalling surgical patties and strips in custom surgical kits due to higher-than-expected endotoxin levels in raw materials. These may result in out-of-specification endotoxin levels in finished sterile products.
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0746-2025·2025-01-01
BD FACSLyric Flow Cytometer Power Supply May Fail During Use
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Product
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0747-2025·2025-01-01
Medical Device Recall: BD FACSLyric Flow Cytometer Power Supply Failure Risk
BD is recalling power supply modules in FACSLyric flow cytometers that may fail to power on or remain powered. Failure could expose lab staff to fumes and cause patient specimen loss or delayed test results.
Product
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tan
Category
Medical Device
Distribution
Distributed nationwide