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.

26726–26750 of 50462

HighFDA (Devices)·Z-0586-2019·2018-12-19
GE Healthcare Recalls B40i Patient Monitors Due to Network Restart Risk
GE Healthcare is recalling 6,864 B40i patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
Product
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0714-2019·2018-12-19
Frutarom Recalls Sebastiano's Hazelnut Syrup for Undeclared Hazelnut Allergen
Frutarom USA Inc. is recalling 17,274 bottles of Sebastiano's Hazelnut Syrup because hazelnuts are not declared in the ingredient or contains statements.
Product
Sebastiano's Naturally Flavored Gourmet Syrups Hazelnut 25.4 fl oz (750 ml)
Category
Food
Distribution
1 state
HighFDA (Food)·F-0725-2019·2018-12-19
Jackie's Cookie Babies Recalled for Potential Metal Fragments
Jackie's Cookie Connection is recalling 9,720 units of Jackie's Cookie Babies Classic Chocolate Chip cookies due to potential metal fragments.
Product
Jackie's Cookie Babies Classic Chocolate Chip Net Wt. 28oz Manufactured and distributed by: Jackie's Cookie Connection, 12109 Santa Monica Blvd., Los Angeles, CA 90025 UPC Code 8 55094 00688 5
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0605-2019·2018-12-19
Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk
Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.
Product
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·18V895000·2018-12-19
Dennis Eagle Elite Refuse Trucks Recalled for Reverse Alarm Mute Switch
Dennis Eagle is recalling 2017-2018 Elite refuse trucks because the reverse alarm mute switch can prevent the vehicle from beeping in reverse, increasing injury risk.
Product
DENNIS EAGLE — DENNIS EAGLE ELITE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0580-2019·2018-12-19
Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
Product
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0584-2019·2018-12-19
GE Healthcare Recalls PROCARE B40 Patient Monitors Due to Network Overload Risk
GE Healthcare is recalling 33,065 PROCARE B40 patient monitors because network configuration issues may cause the devices to restart unexpectedly.
Product
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0562-2019·2018-12-19
CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO Medical Instruments is recalling 738 boxes of Needle Guide Brackets because they may puncture the sterile cover during assembly.
Product
CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0700-2019·2018-12-19
Imperial Taste Fried Red Onion Recalled for Undeclared Wheat
Gemini Food Corporation is recalling Imperial Taste Fried Red Onion because an investigation found undeclared wheat in the ingredients.
Product
Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 741861017607; 24 x 12oz. Item #1761, UPC Code: 741861017614; Ingredients: Red Onion, Palm Oil Product of Vietnam Distributed by Gemini Food Corporation, City Of Inductry, CA 91789
Category
Food
Distribution
34 states
HighNHTSA·18V908000·2018-12-19
Mercedes-Benz Recalls 2018 S-Class Vehicles for Steering Assist Defect
Mercedes-Benz is recalling 2018 S-Class and AMG S63 vehicles because an incorrect steering boot installation may keep the Active Steering Assist system engaged while the driver's hands are off the wheel.
Product
MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 560 4MATIC, AMG S63, S 450, S560
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2019·2018-12-19
Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.
Product
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0578-2019·2018-12-19
Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to potential broken seals that compromise sterility.
Product
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
Category
Medical Device
Distribution
1 state
HighNHTSA·18V906000·2018-12-19
Mercedes-Benz Recalls 2018 C300 Models for Headlight Adjustment Defect
Mercedes-Benz is recalling 2,364 2018 C300 and C300 4MATIC vehicles because improperly adjusted headlights may reduce driver visibility and increase crash risk.
Product
MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ C 300 4MATIC, C 300
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0701-2019·2018-12-19
Fried Garlic Recalled for Undeclared Wheat Ingredient
Gemini Food Corporation is recalling Imperial Taste Fried Garlic due to undeclared wheat. The product is distributed in multiple states.
Product
Imperial Taste Fried Garlic, Tu Phi; 24 x 8oz. Item #1763 UPC Code: 741861017638; 24 x 12oz. Item #1762 UPC Code: 741861017621 Ingredient: Garlic, Palm Oil Product of Vietnam Distributed by Gemini Food Corporation, City of Industry, CA
Category
Food
Distribution
34 states
HighNHTSA·18V911000·2018-12-19
Mercedes-Benz Recalls 2019 CLS Models for Headlight Adjustment Defect
Mercedes-Benz is recalling 2019 CLS 450 and AMG CLS53 vehicles because unsealed headlight adjustment screws may cause improper alignment, increasing crash risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ CLS 450, AMG CLS53
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V900000·2018-12-19
Toyota Recalls 2019 Tundra Trucks Due to Incorrect Load Capacity Labels
Toyota is recalling 2019 Tundra trucks with spray-in bed liners because incorrect load capacity labels may lead to overloading and increased crash risk.
Product
TOYOTA — TOYOTA TUNDRA
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2019·2018-12-19
GE Healthcare Recalls PROCARE B20 Patient Monitors Due to Network Issues
GE Healthcare is recalling 28,004 PROCARE B20 patient monitors because network configuration issues may cause the devices to restart unexpectedly.
Product
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0563-2019·2018-12-19
CIVCO Recalls SonoSite L25 Bracket Kits Due to Puncture Risk
CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.
Product
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0579-2019·2018-12-19
Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
Product
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0587-2019·2018-12-19
GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk
GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
Product
B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2019·2018-12-19
Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component
Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.
Product
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Category
Medical Device
Distribution
32 states
HighCPSC·19055·2018-12-19
GNC Recalls Women's Iron Complete Supplements Due to Packaging Defect
GNC is recalling Women's Iron Complete supplements because the blister packaging is not child-resistant, posing a risk of poisoning to children.
Product
Women's Iron Complete Dietary Supplement (60 caplets)
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0593-2019·2018-12-19
St. Jude Medical DBS Leads Recalled for Incorrect Electrode Material
St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.
Product
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0704-2019·2018-12-19
4Patriots Chicken a la King Recalled for Undeclared Milk Allergen
4Patriots, LLC is recalling Chicken a la King pouches because milk is not declared on the label. The product was sold nationwide in emergency kits.
Product
4Patriots Chicken a la King CONTAINS: Wheat, Coconut NET WT. 10.0 oz (284 g)
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0564-2019·2018-12-19
CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.
Product
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Category
Medical Device
Distribution
0 states