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.

34101–34125 of 50502

HighFDA (Devices)·Z-0322-2017·2016-11-09
Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction
Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.
Product
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0330-2017·2016-11-09
Azer Scientific Recalls Fruit Punch Glucose Due to Microbiological Test Failures
Azer Scientific is recalling Fruit Punch Glucose, 100 Gram Concentration, due to out-of-specification microbiological test results.
Product
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2017·2016-11-09
Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure
Hospira is recalling Symbiq Two Channel Infusers due to a backup battery failure caused by incorrect component installation on some power supply boards.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0332-2017·2016-11-09
Spacelabs Xhibit Central Station Recalled for Telemetry Display Issues
Spacelabs Healthcare is recalling 348 Xhibit Central Station units because telemetry SpO2 numerics may drop off the display, though alarms function normally.
Product
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0355-2017·2016-11-09
Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk
Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.
Product
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0340-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0356-2017·2016-11-09
Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk
Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.
Product
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used…
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-0382-2017·2016-11-09
Beverage International Recalls Nu-Quench Lime Bar Mix Due to Undeclared Dye
Beverage International is recalling Nu-Quench Lime Bar Mix because it contains undeclared Yellow #5, a potential allergen for sensitive individuals.
Product
Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0339-2017·2016-11-09
Stryker Neurovascular Recalls Guider Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing defect that could cause hub leaks.
Product
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0324-2017·2016-11-09
Stryker Recalls Reprocessed Pressure Tourniquet Cuffs Due to Leak Detection Issues
Stryker Sustainability Solutions is recalling 1,695,760 reprocessed pressure tourniquet cuffs because the process for detecting leaks is flawed. Leaking cuffs may cause excessive blood loss or systemic leakage of local anesthetic.
Product
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2017·2016-11-09
Maquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk
Maquet Cardiovascular is recalling 305 HCU 30 units because contaminated water, including Mycobacteria, may enter the device circuits.
Product
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2017·2016-11-09
Stryker Recalls Guider Guide Catheters Due to Manufacturing Defect
Stryker Neurovascular is recalling 1,478 Guider Guide Catheters worldwide due to a manufacturing non-conformance that could lead to hub leaks.
Product
Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0341-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters worldwide due to a manufacturing defect that may cause hub leaks.
Product
Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0347-2017·2016-11-09
Stryker Recalls Guider Softip XF Guide Catheters Due to Hub Leaks
Stryker Neurovascular is recalling Guider Softip XF guide catheters because a manufacturing defect may cause hub leaks in the devices.
Product
Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-0321-2017·2016-11-09
JJBL LLC Recalls Chocolate Bars Due to Undeclared Wheat
JJBL LLC is recalling The Most Awesome Chocolate Bar Ever because the product contains undeclared wheat. The recall affects 2,214 bars distributed in 11 states.
Product
The Most Awesome Chocolate Bar Ever, Net wt. 1.5 oz. UPC 8 55966 00178 9.
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-0350-2017·2016-11-09
Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves
Smith & Nephew is recalling 2,352 Tandem hip shells manufactured with out-of-specification retainer grooves. The recall covers units distributed nationwide and in 23 other countries.
Product
TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0379-2017·2016-11-09
Frontera Taco Skillet Sauce Recalled for Undeclared Soy
Riba Foods Inc is recalling Frontera Texas Original Taco Skillet Sauce due to potential undeclared soy from soy sauce.
Product
Frontera Texas Original Taco Skillet Sauce with mild red chile + cumin 8 oz. pouch
Category
Food
Distribution
0 states
HighFDA (Food)·F-0311-2017·2016-11-09
Fanega Flour Tortillas Recalled for Undeclared Wheat Allergen
Fanega Mexican Food Products is recalling 10-inch flour tortillas sold in Arizona because they contain undeclared wheat.
Product
10" Flour Tortillas 12 count, Net Wt. 25oz (732g)
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0360-2017·2016-11-09
Unomedical Recalls SureT G29 Insulin Infusion Pump Tubing Due to Detachment Risk
Unomedical As is voluntarily recalling SureT G29 insulin infusion pump tubing because it may detach. The recall covers 4,748,000 units distributed in the US and internationally.
Product
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0353-2017·2016-11-09
Hospira Recalls Symbiq Infusion Pumps Due to Backup Battery Failure
Hospira is recalling 20,311 Symbiq One Channel Infusion Pumps due to a backup battery failure caused by incorrect component installation on some power supply boards.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2017·2016-11-09
Smith & Nephew Recalls Tandem Hip Shells With Out-of-Specification Grooves
Smith & Nephew is recalling 5,806 Tandem hip shell units manufactured with out-of-specification retainer grooves. The recall covers distribution in the US and 23 other countries.
Product
TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2017·2016-11-09
Unomedical Silhouette Insulin Infusion Tubing Recalled for Detachment Risk
Unomedical As is recalling Silhouette and Silhouette Paradigm insulin infusion tubing due to a risk of tubing detachment. The recall affects approximately 9.8 million units distributed in the US and internationally.
Product
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0329-2017·2016-11-09
Azer Scientific Recalls Glucose Tolerance Beverage Due to Microbiological Test Failures
Azer Scientific, Inc. is recalling 426 cases of Orange Glucose Tolerance Beverage due to out-of-specification microbiological test results.
Product
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0323-2017·2016-11-09
Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard
Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.
Product
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
Category
Medical Device
Distribution
4 states