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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1151–1175 of 26417

HighFDA (Food)·H-0551-2026·2026-03-18
Frozen Blueberry Crumble Pie Recalled for Listeria Risk
Willamette Valley Pie Company is recalling Frozen Raw Bulk 9 inch Blueberry Crumble Pie due to potential contamination with listeria monocytogenes. The frozen pies were sold to grocery retailers' in-store bakeries in Illinois and Oregon.
Product
Frozen Raw Bulk 9 inch Blueberry Crumble Pie ES (4 pies/case). Net wt. 38oz. UPC 00022518893257. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are inte
Category
Food
Distribution
2 states
HighFDA (Food)·H-0554-2026·2026-03-18
Coco's Italian Market Cannoli Making Kit Missing Allergen Declarations
Coco's Italian Market Cannoli Making Kit is recalled because the label lists flour and ricotta cheese as sub-ingredients but fails to declare wheat and milk allergens. Consumers with wheat or milk allergies may be at risk if they consume the product.
Product
Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716
Category
Food
Distribution
1 state
HighFDA (Food)·H-0550-2026·2026-03-18
Frozen Raw Blueberry Crumble Pie Recalled for Listeria Risk
Willamette Valley Pie Company is recalling frozen raw blueberry crumble pies due to potential listeria monocytogenes contamination. The pies were distributed to grocery store in-store bakeries in Illinois and Oregon.
Product
Frozen Raw Bulk 8 inch Blueberry Crumble Pie (4 pies/case). Net wt. 24.5oz. UPC 0002251881223. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen Raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are intende
Category
Food
Distribution
2 states
HighFDA (Food)·H-0621-2026·2026-03-18
House of Flavors Vanilla Ice Cream Recalled for Undeclared Egg
House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream (3 gallon tubs) is being recalled because it contains undeclared egg, a common allergen. The recall affects 4,880 tubs distributed in Illinois.
Product
House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream, 3 GAL tub
Category
Food
Distribution
1 state
HighFDA (Food)·H-0614-2026·2026-03-18
CNC Noodle Corporation Fresh Noodles Recall for Undeclared Allergens
CNC Noodle Corporation is recalling ZHONG HUA CHAO MIAN fresh noodles due to undeclared wheat and Yellow #6 food coloring on the label. Consumers with wheat allergies or sensitivities to the colorant may be at risk.
Product
Secondary Packaging: ZHONG HUA CHAO MIAN NOODLE INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVE F.D. & C. YELLOW COLOR #5 & #5 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. FRESH NOODLE NET W
Category
Food
Distribution
2 states
HighFDA (Food)·H-0553-2026·2026-03-18
Coco's Italian Market Fettuccini Alfredo recalled for undeclared wheat
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo is recalled because the label lists semolina and durum flour as sub-ingredients but does not declare wheat. Consumers with wheat allergies or sensitivities may be at risk.
Product
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt. 19 oz. (510g), Keep Frozen, packaged in a microwaveable plastic container, UPC 0680334993607
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1511-2026·2026-03-18
Orthopedic implant connection component recalled due to potential bushing detachment
Waldemar Link is recalling Endo-Model SL Connection Component implants due to potential bushing detachment from the plateau screw caused by longitudinal fracture. 44 units affected worldwide.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1498-2026·2026-03-18
Raz Mobile Shower Commode Chair Seat Brackets May Fail to Properly Engage
Raz mobile shower commode chair seats may not be properly secured due to vendor modifications that can cause rear seat brackets to fail to engage, creating instability risk for mobility-impaired users.
Product
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1520-2026·2026-03-18
Endo-Model Replacement Plateau implant screw bushing may detach
The Endo-Model Replacement Plateau implant is being recalled because the screw bushing may detach due to a longitudinal fracture, potentially compromising implant function.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2026·2026-03-18
Exactech Equinoxe Ergo Impactor Handles Recalled for Missing Cross-Pin
Exactech is recalling 120 units of Equinoxe Ergo Modular Impactor Handles (Model 321-09-05) because the handle may be missing a cross-pin, a structural component that could compromise surgical function.
Product
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1549-2026·2026-03-18
APTUS 2.5 TriLock Screws: Dimensional Mix-up with Incorrect Diameter
Medartis is recalling APTUS 2.5 TriLock Screws (Lot 25472432) due to a mix-up between 2.5mm and 2.8mm diameter screws. Using the wrong diameter screw could compromise proper surgical fixation.
Product
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 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-1556-2026·2026-03-18
Artelon FLEXBAND TWIST surgical augmentation devices recalled for failed endotoxin testing
Artelon FLEXBAND TWIST surgical augmentation devices failed bacterial endotoxin testing. The recall affects devices distributed nationwide and internationally; contact your healthcare provider if you received this device.
Product
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1557-2026·2026-03-18
Remote Patient Monitoring System Alarm Transmission Failure Recall
Covidien's Vital Sync remote patient monitoring systems may fail to transmit critical alarms from bedside monitors to the central monitoring platform, potentially delaying clinical alerts.
Product
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 /
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1560-2026·2026-03-18
Clearest Strep-A Cassette Test recalled for lacking FDA clearance
Altruan GmbH is recalling the Clearest Strep-A Cassette Test because the product has not been cleared by the FDA. The test detects group A streptococci in throat swab samples.
Product
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1554-2026·2026-03-18
Medical augmentation devices recalled for failed bacterial endotoxin testing
International Life Sciences is recalling Artelon FlexBand Dynamic Matrix augmentation devices due to failed bacterial endotoxin testing. The devices were distributed nationwide and internationally.
Product
Artelon FlexBand Dynamic Matrix Ref: 31057
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1525-2026·2026-03-18
GEM Premier 5000 PAK Cartridges May Eject During Warm-Up
Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges that may experience increased ejection errors during warm-up, potentially delaying laboratory test results.
Product
GEM Premier 5000 PAK; Part No. 00055360008.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1542-2026·2026-03-18
GEM Premier 5000 Cartridges Recalled for Control Solution Detection Errors
Instrumentation Laboratory is recalling GEM PAK cartridges for the GEM Premier 5000 due to increased failures in process control detection during warm-up, which may cause cartridge ejection and delay laboratory test results.
Product
GEM Premier 5000; Part No. 00055445008.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1544-2026·2026-03-18
Physio-Control Infant and Child Defibrillator Electrodes Recalled for Delamination
Physio-Control is recalling Infant/Child Reduced Energy Defibrillator Electrodes due to delamination of the electrode material that could affect proper functioning during emergency treatment of pediatric patients.
Product
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1555-2026·2026-03-18
Surgical Augmentation Devices Recalled for Bacterial Endotoxin Testing Failure
International Life Sciences recalls Artelon FlexBand Plus surgical devices (Ref 41054, 41057) worldwide due to bacterial endotoxin contamination discovered during testing.
Product
Artelon FlexBand Plus Ref: 41054 & 41057
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1551-2026·2026-03-18
EndoVive Safety PEG Kit Recall Due to Compromised Swabstick Packaging
Boston Scientific is recalling EndoVive Safety PEG Kits due to open or compromised seals on included ChloraPrep Triple Swabsticks that could result in loss of sterility or drying of antiseptic solution.
Product
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1552-2026·2026-03-18
Clinical Chemistry Analyzer Database Error Causes System Failure
When left open beyond 15 minutes, certain DxC 700 AU analyzers experience database errors causing system failure. The analyzer stops working and requires a service call to restore operation.
Product
DxC 700 AU, REF: B86444, B86446
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1540-2026·2026-03-18
GEM Premier 5000 Analyzer Cartridges May Eject During Warm-Up
GEM PAK cartridges for the GEM Premier 5000 blood analyzer may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejections and potentially delaying test results.
Product
GEM Premier 5000; Part No. 00055430011.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1529-2026·2026-03-18
GEM Premier 5000 cartridges may fail repeatedly during warm-up, delaying test results
Certain GEM Premier 5000 cartridges may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejection and delayed test results. Affected units were distributed worldwide.
Product
GEM Premier 5000 PAK; Part No. 00055407508.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1563-2026·2026-03-18
Medline Medcrest Surgical Gowns Prone to Premature Fabric Delamination
Medline Medcrest surgical gowns may delaminate when laundered, risking surgical barrier failure and infection. The FDA has recalled 104,004 units distributed nationwide and internationally.
Product
Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1535-2026·2026-03-18
GEM Premier 5000 Cartridges Recalled for Process Control Errors
GEM PAK cartridges for the GEM Premier 5000 laboratory analyzer may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejection and operational disruption. The affected product includes 1,629 units distributed worldwide.
Product
GEM Premier 5000; Part No. 00055415010.
Category
Medical Device
Distribution
Distributed nationwide