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.

45126–45150 of 50512

HighFDA (Food)·F-1962-2012·2012-08-29
Flywheel's Pies Recalls Lemon Pies Due to Undeclared Allergens
Flywheel's Pies is recalling Lemon Pies because they contain undeclared partially hydrogenated soybean oil and wheat.
Product
Lemon Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2220-2012·2012-08-29
DePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling
DePuy Orthopaedics is recalling 20 Altralinked polyethylene liners because a size 52 liner was incorrectly labeled as size 54.
Product
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2258-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2012·2012-08-29
GE OEC Recalls 9800 Fluoroscopic X-Ray Systems Due to Hard Drive Defects
GE OEC is recalling 9800 fluoroscopic x-ray systems because a replacement hard drive can cause system shutdowns, data loss, or data corruption.
Product
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1961-2012·2012-08-29
Flywheel's Pies Recalls Coconut Pies for Undeclared Allergens
Flywheel's Pies is recalling coconut pies sold in Arkansas due to undeclared soy lecithin, soybean oil, and wheat.
Product
Coconut Pies: Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2231-2012·2012-08-29
Terumo Advanced Perfusion System 1 Serial Interface Module Recall
Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.
Product
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1966-2012·2012-08-29
Breadfarm Whiskey Pecan Cookies Recalled for Metal Fragment Contamination
Breadfarm is recalling Whiskey Pecan Cookies because the wheat germ used in the dough was potentially contaminated with metal fragments.
Product
Whiskey Pecan Cookies, packaged in cellophane sleeve wrap, 9.6 oz each. Sold in individual sleeves or in a case of 6 packages (cello sleeves).
Category
Food
Distribution
1 state
HighFDA (Food)·F-1955-2012·2012-08-29
Flywheel's Pies Recalls Blueberry Pies for Undeclared Soybean Oil and Wheat
Flywheel's Pies is recalling Blueberry Pies sold in Arkansas because the product contains undeclared partially hydrogenated soybean oil and wheat.
Product
Blueberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE, FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2245-2012·2012-08-29
Philips CT Systems Recalled for Potential Patient Support Movement
Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.
Product
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1956-2012·2012-08-29
Flywheel's Raisin Pies Recalled for Undeclared Soybean Oil and Wheat
Flywheel's Pies is recalling Raisin Pies sold in Arkansas due to undeclared partially hydrogenated soybean oil and wheat.
Product
Raisin Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almon, Salt Pie…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2232-2012·2012-08-29
Terumo Interface Module Recall for Data Transfer Malfunctions
Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.
Product
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1953-2012·2012-08-29
Flywheel's Pies Recalls Peach Pies for Undeclared Allergens
Flywheel's Pies is recalling Peach Pies sold in Arkansas due to undeclared soy lecithin, partially hydrogenated soybean oil, and wheat.
Product
Peach Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt Pie…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2226-2012·2012-08-29
Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
Product
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2012·2012-08-29
GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection
GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.
Product
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1984-2012·2012-08-29
Winn-Dixie Recalls Southern Home Cranberry Nut Trail Mix for Undeclared Soy
Winn-Dixie is recalling Southern Home Cranberry Nut Antioxidant Blend trail mix because it contains undeclared soy lecithin.
Product
Southern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, SC 29662.
Category
Food
Distribution
1 state
HighFDA (Food)·F-1947-2012·2012-08-29
KT Specialty Foods Recalls Cheese Pizza Due to Temperature Control Issues
KT Specialty Foods Inc. is recalling Cheese Pizza in Oregon and Washington because it was not kept at safe temperatures to prevent pathogen growth.
Product
Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk.
Category
Food
Distribution
2 states
HighFDA (Food)·F-1964-2012·2012-08-29
Flywheel's Pies Recalls Blackberry Pies for Undeclared Soybean Oil and Wheat
Flywheel's Pies is recalling Blackberry Pies sold in Arkansas due to undeclared partially hydrogenated soybean oil and wheat.
Product
Blackberry Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt
Category
Food
Distribution
1 state
HighFDA (Food)·F-1968-2012·2012-08-29
Breadfarm Recalls Fig Bars Due to Potential Metal Fragment Contamination
Breadfarm is recalling bulk-packed Fig Bars because the wheat germ used in production was potentially contaminated with metal fragments.
Product
Fig Bars (Fig Newton style), bulk packed and refrigerated for individual sales.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2252-2012·2012-08-29
AGFA Medical Image Storage Device Recall for Data Loss Risk
AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.
Product
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2012·2012-08-29
Siemens EasyLink Informatic System Recalled for Quality Control Defect
Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.
Product
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2012·2012-08-29
Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating
Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.
Product
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2236-2012·2012-08-29
GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard
GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.
Product
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1949-2012·2012-08-29
KT Specialty Foods Recalls Veggie Pizza Due to Temperature Control Failure
KT Specialty Foods Inc. is recalling 20 units of bulk Veggie Pizza in Oregon and Washington because the product lacked temperature control, posing a risk of pathogen growth.
Product
Veggie Pizza. Label is not provided. Product is packaged and delivered in bulk.
Category
Food
Distribution
2 states
HighCPSC·12261·2012-08-29
Cooper Lighting Recalls Shower Light Trim Due to Falling Hazard
Cooper Lighting is recalling shower light trims because the trim and glass lens can fall from the ceiling, posing impact and laceration hazards.
Product
Shower light trim
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative…
Category
Medical Device
Distribution
Distributed nationwide