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.

5576–5600 of 52957

HighFDA (Devices)·Z-1014-2025·2025-01-29
Dressing Change Kits Recalled for Potential Package Sterility Compromise
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0985-2025·2025-01-29
Medtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
Product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2025·2025-01-29
Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
Product
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Product
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2025·2025-01-29
Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.
Product
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0422-2025·2025-01-29
Frozen Buttered Vegetables Recall Due to Undeclared Milk Allergen
Lidl's frozen buttered vegetables are recalled because the product labels do not disclose milk as an ingredient. Approximately 35,320 units distributed across nine states are affected.
Product
Buttered Vegetables KEEP FROZEN NET WT 10.5 OZ (300g) INGREDIENTS: CARROTS, PEAS, CALIFLOWER, CORN, BUTTER, SUGAR, SALT, CORN STARCH, PARSLEY MAY CONTAIN WHEAT. DISTRIBUTED BY LIDL USA, LLC. 3500 S. CLARK STREET, ARLINGTON, VA 22202 UPC 4 056489 122876
Category
Food
Distribution
10 states
HighFDA (Food)·F-0419-2025·2025-01-29
Butter Toffee Almonds recalled for undeclared milk allergen
Cal Yee Farm LLC recalls Butter Toffee Almonds for undeclared milk. Products affected: Cal Yee's (8-oz, 1-lb bags) and Boa Vista (6-oz bag). Distribution: 2 California retail stores and online/phone orders to California and Pennsylvania.
Product
Cal Yee's Butter Toffee Almonds (8-oz, 1-lb plastic bags) Boa Vista Butter Toffee Almonds (6-oz plastic bag)
Category
Food
Distribution
2 states
HighFDA (Food)·F-0406-2025·2025-01-29
Horizon Organic Aseptic Plain Whole Milk Recalled for Potential Premature Spoilage
Horizon Organic Aseptic Plain Whole Milk may spoil before its expiration date. The recalled products were distributed in Arizona, California, and Nevada.
Product
Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 3663207127 (single unit). Distributed by: Danone US, LLC Broomfield, CO 80021. HOD (Horizon Organic Dairy) #: 140236
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1007-2025·2025-01-29
VITROS 3600 Diagnostic System May Fail to Alert Users to Expired Reagents
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Product
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter pr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2025·2025-01-29
Wolf-Pak Dressing Change Kits Recalled Due to Package Defects
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2025·2025-01-29
CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings
St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.
Product
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0999-2025·2025-01-29
Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips
Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2025·2025-01-29
BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures
BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.
Product
BD Pyxis MedStation 4000 Main, REF 303
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1012-2025·2025-01-29
Dressing change kits recalled due to packaging defect compromising sterility
Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.
Product
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2025·2025-01-29
Baxter Clearlink system solution sets recalled for clamp defect
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
Product
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2025·2025-01-29
Olympus Thunderbeat surgical instrument probe tips may damage or break
Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424110¿ Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2025·2025-01-29
Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2025·2025-01-29
Dressing Change Tray Recalled Due to Potential Package Sterility Compromise
Trinity Sterile's Dressing Change Tray (Model TM6180CP, Lot 600032) is recalled because of a potential hole in the package that could compromise sterility. The recall affects 280 units distributed across Maryland, Pennsylvania, Tennessee, and Texas.
Product
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2025·2025-01-29
BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis MedStation 4000 AUX, REF 306
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0998-2025·2025-01-29
Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2025·2025-01-29
BD Pyxis Med 4000 Auxiliary Drawer and Door Failures Delay Medication Access
CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1003-2025·2025-01-29
Olympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage
Olympus is recalling Thunderbeat hand instruments (Model TB-0535FCS) because probe tips can be damaged or break during use. The recall affects 27,352 units distributed internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N5423810 Software Version: N/A Product Description: Thunderbeat instrument is a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2025·2025-01-29
Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0206-2025·2025-01-29
First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations
First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.
Product
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
Category
Drug
Distribution
Distributed nationwide