Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

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1126–1150 of 26417

SevereFDA (Devices)·Z-1545-2026·2026-03-18
Blood Glucose Meter Instructions Lack Clear E-5 Error Code Guidance
Trividia Health is recalling instructions for TRUE METRIX blood glucose meters because E-5 error code guidance is inadequate, potentially delaying treatment for dangerously high blood sugar levels.
Product
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GN
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0561-2026·2026-03-18
Made Fresh Salads Lox Cream Cheese recalled for Listeria contamination
Made Fresh Salads brand Lox Cream Cheese (5 lb tubs) is recalled due to potential Listeria monocytogenes contamination. Consumers should not consume affected products.
Product
Made Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1548-2026·2026-03-18
Blood glucose monitor instructions recalled for unclear error code labeling
Trividia Health is recalling TRUE METRIX GO blood glucose monitor instruction manuals because the labeling fails to clearly explain what an E-5 error code means or when to seek medical help, risking delayed treatment for high blood glucose emergencies.
Product
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/R
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1547-2026·2026-03-18
Blood glucose monitor instructions inadequately label critical error code E-5
Instructions for TRUE METRIX AIR blood glucose meters are recalled for inadequately explaining the E-5 error code, which can indicate dangerously high blood sugar. Users may not recognize the need to seek immediate medical attention.
Product
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1546-2026·2026-03-18
Blood Glucose Meter Instructions Inadequately Label Critical E-5 Error Code
Trividia Health recalls Owner's Booklets for TRUE METRIX PRO blood glucose meters because labeling inadequately explains the E-5 error code, which can represent very high blood glucose levels. Unclear instructions could delay medical attention when users experience this critical error.
Product
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2026·2026-03-18
Surgical Instrument Kit Recalled for Missing Cross-Pin in Impactor Handle
Exactech is recalling the Equinoxe Core Instrument Kit because the impactor handle may be missing a cross-pin, potentially affecting surgical instrument functionality and safety. Approximately 596 kits were distributed across the United States and internationally.
Product
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1497-2026·2026-03-18
Proton Therapy System Safety Interface Disabled, Mistreatment Risk
Some PROTEUS 235 proton therapy systems have a disabled safety feature that could fail to stop radiation beam delivery if an external gating device loses signal, potentially causing patient overexposure.
Product
IBA Proton Therapy System - PROTEUS 235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1558-2026·2026-03-18
CLARITY II Laser System recalled due to sparking and patient burn risk
The CLARITY II Laser System by Lutronic is being recalled following reports of devices sparking and popping, which may burn patients during use. The recall affects 1,525 units distributed worldwide.
Product
CLARITY II Laser System; Model No. 1110200210.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1514-2026·2026-03-18
Endo-Model SL Implant Connection Component Recalled for Bushing Detachment Risk
An implant connection component manufactured by Waldemar Link may experience bushing detachment due to a longitudinal screw fracture. The recall affects 31 units distributed in the United States and internationally.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2026·2026-03-18
Orthopedic Implant Plateau Recalled for Potential Bushing Detachment Risk
Waldemar Link is recalling Endo-Model Replacement Plateau implants (Item 15-2836/11) due to potential bushing detachment from the screw shaft caused by longitudinal fracture. Seven units affected worldwide including the US. No injuries reported.
Product
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2026·2026-03-18
APTUS TriLock Screw mix-up between 2.5mm and 2.8mm models
Medartis AG is recalling certain lots of APTUS 2.8 TriLock Screws due to a mix-up with 2.5mm screws. The dimensional error could affect the fit and stability of orthopedic fixation in hand, forearm, shoulder, and foot surgery.
Product
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1522-2026·2026-03-18
Endo-Model plateau screw implants recalled due to potential bushing failure
Waldemar Link is recalling Endo-Model Replacement Plateau implants because the bushing could detach from the screw shaft due to a longitudinal fracture. This could compromise implant stability.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2026·2026-03-18
Endo-Model Replacement Plateau Orthopedic Implants Recalled for Screw Bushing Detachment
Waldemar Link is recalling 3 units of Endo-Model Replacement Plateau orthopedic implants due to potential detachment of the bushing from the screw shaft. The defect results from a longitudinal fracture in the screw.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1517-2026·2026-03-18
Endo-Model Replacement Plateau Screw Recalled for Bushing Detachment Risk
Waldemar Link recalls its Endo-Model Replacement Plateau due to potential bushing detachment from the screw shaft, which could cause implant failure. Four units were affected and distributed worldwide.
Product
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0400-2026·2026-03-18
Icosapent Ethyl Prescription Capsules Recalled for Oxidized Active Ingredient and Melted Capsules
Zydus Pharmaceuticals is recalling approximately 60,541 bottles of Icosapent Ethyl 1-gram capsules nationwide due to capsule defects, including melted capsules and red dots caused by oxidized active ingredient. No illnesses have been reported.
Product
ICOSAPENT ETHYL — ICOSAPENT ETHYL (ICOSAPENT ETHYL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1512-2026·2026-03-18
Waldemar Link Endo-Model Replacement Plateau Implant Bushing Detachment Risk
Waldemar Link is recalling Endo-Model Replacement Plateau implants due to risk that the bushing could detach from the screw shaft due to longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1515-2026·2026-03-18
Endo-Model Replacement Plateau Screw Bushing Could Detach During Use
Waldemar Link is recalling Endo-Model Replacement Plateau surgical implants due to potential bushing detachment from the screw shaft. The defect could cause implant failure.
Product
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1521-2026·2026-03-18
Endo-Model Replacement Plateau orthopedic implant: bushing detachment risk
Waldemar Link is recalling Endo-Model Replacement Plateau implants due to the potential for bushing detachment from the screw shaft caused by longitudinal fracture. Affected units were distributed in the US and worldwide.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1524-2026·2026-03-18
GEM Premier 5000 PAK Cartridges Recalled for Increased Ejection Failures
Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to an increased incidence of cartridge ejection errors during device warm-up, which may delay lab result turnaround times.
Product
GEM Premier 5000 PAK, Part No. 00055360004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1553-2026·2026-03-18
Chemistry Analyzer Software Defect Disables System and Delays Diagnosis
Beckman Coulter's Chemistry Analyzer AU5800 may fail when the calibration monitor is open beyond 15 minutes, halting patient analysis and potentially delaying diagnosis.
Product
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1538-2026·2026-03-18
GEM Premier 5000 Analyzer Cartridges May Malfunction During Warm-Up
Instrumentation Laboratory is recalling 74 units of GEM Premier 5000 analyzer cartridges that may malfunction during warm-up, causing cartridge ejection and potentially delaying patient test results.
Product
GEM Premier 5000; Part No. 00055430008.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1533-2026·2026-03-18
GEM Premier 5000 Lab Analyzer Cartridges May Eject During Testing
GEM Premier 5000 lab cartridges may eject repeatedly during warm-up, requiring replacement and potentially delaying patient test results. No illnesses or injuries have been reported.
Product
GEM Premier 5000; Part No. 00055415005.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0549-2026·2026-03-18
Hortex Mieszanka 9 Spring Vegetable Mix Recalled for Potential Glass Contamination
Polski Ogrod Sp. z o.o. is recalling Hortex Mieszanka 9 Spring vegetable mix due to potential glass contamination. The affected product was distributed in Illinois.
Product
Hortex Mieszanka 9 - skBadnikowa Spring vegetable mix with 9 ingredients, net wt 15.87oz., UPC 5 900477 018735 >, 14 units per case
Category
Food
Distribution
1 state
HighFDA (Food)·H-0613-2026·2026-03-18
CNC Noodle Corporation Steam Noodles Recalled for Undeclared Wheat
CNC Noodle Corporation is recalling China Noodle Co. Steam Noodle packages due to undeclared wheat in the product, which poses a risk to consumers with wheat allergies.
Product
Secondary Packaging: STEAM NOODLES INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVEM F.D. & C. YELLOW COLOR #5 & #6 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. STEAM NOODLE NET WEIGHT 10 LBS
Category
Food
Distribution
2 states
HighFDA (Food)·H-0548-2026·2026-03-18
Vegetarian Chicken Flavor Ramen Express contains undeclared Yellow #5
Palmetto Gourmet Foods Inc. is recalling Vegetarian Chicken Flavor Ramen Express because the product contains undeclared Yellow #5 food coloring, a major allergen for some consumers.
Product
VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Palm oil***" Contains: Wheat, Soy. UPC 8 10037 81004 2 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138
Category
Food
Distribution
32 states