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.

23126–23150 of 50433

HighFDA (Devices)·Z-1989-2020·2020-05-20
Dover Silicone Foley Catheter Recall for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration standards, posing a risk of incorrect patient diagnosis.
Product
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1937-2020·2020-05-20
Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect
Argon Medical Devices is recalling Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.
Product
Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1976-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 1,864 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL kits because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1943-2020·2020-05-20
Handicare Recalls EVA Floor Lifts Due to Potential Joint Failure
Handicare AB is recalling 997 EVA Floor Lifts (Models 400, 450, 600) in the US and Mexico because abnormal use could cause the liftarm joint to break, posing an injury risk.
Product
EVA Floor Lifts, Model Numbers: 400, 450, 600
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1936-2020·2020-05-20
Argon Medical Devices Recalls Arterial Line Kits Due to Needle Defect
Argon Medical Devices is recalling 150 Arterial Line Kits because they contain a thicker suture and curved needle that may increase the risk of needle sticks.
Product
Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required. Case Label…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0939-2020·2020-05-20
Joseph's Gluten Free Original Wrap Recalled for Containing Gluten
Middle East Bakery is recalling Joseph's Gluten Free Original Wraps because the product contains gluten, posing a risk to consumers with celiac disease or gluten sensitivity.
Product
Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-1958-2020·2020-05-20
Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.
Product
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0946-2020·2020-05-20
Essential Baking Company Recalls Organic Sliced Columbia Bread for Undeclared Egg
The Essential Baking Company is recalling 84 loaves of Organic Sliced Columbia bread in Washington due to undeclared egg.
Product
The product is twisted bread and packaged in a flexible plastic bag with a yellow Kwik-Lok seal. The label is read in parts: "***ORGANIC SLICED COLUMBIA*** Net Weight 32 ounces *** The ESSENTIAL BAKING Company***INGREDIENTS: Organic Unbleached Wheat Flour, Water, Organic…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1994-2020·2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling specific Dover Foley catheters because their temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·20V289000·2020-05-20
Vac-Tron Recalls 2016-2020 Vacuum Excavator Trailers for Lighting Defects
Vac-Tron is recalling 2016-2020 vacuum excavator trailers because improper lighting and missing reflectors may reduce visibility, increasing crash risk.
Product
VAC-TRON — VAC-TRON CS 570 GT, CS 1273 GT, CS 1270 SGT, CS 1270 GT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1953-2020·2020-05-20
Cardiac Assist Recalls Six TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling six TandemHeart pump kits because an assembly error may prevent the device from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1980-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 4,187 saline flush syringes used in vascular kits because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1992-2020·2020-05-20
FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures
FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead to incorrect patient diagnoses.
Product
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 6,254 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 2,697 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1947-2020·2020-05-20
Sunrise Medical Recalls Quickie and Zippie Powered Wheelchairs Due to Controller Error
Sunrise Medical is recalling specific Quickie and Zippie powered wheelchairs because a controller programming error allows users to set motor parameters beyond safe limits.
Product
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2003-2020·2020-05-20
Inpeco FlexLab Interface Module Recalled for Sample Cross-Contamination Risk
Inpeco S.A. is recalling 82 FlexLab Interface Modules because a timeout error could cause sample cross-contamination.
Product
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1948-2020·2020-05-20
Cardiac Assist Recalls TandemHeart Pump Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 10 TandemHeart Pump Kits because an assembly error may prevent the device from priming.
Product
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leakage
BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.
Product
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2020·2020-05-20
Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures
FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.
Product
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1982-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Flush Syringes Due to Packaging Defects
Access Scientific LLC is recalling 50 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1961-2020·2020-05-20
Intuitive Surgical Recalls da Vinci X Systems Due to Arm Fault
Intuitive Surgical is recalling 74 da Vinci X Surgical Systems because a manufacturing variation in the arm can cause a fault error and loss of functionality during surgery.
Product
da Vinci X Surgical System
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1981-2020·2020-05-20
Access Scientific Recalls Pediatric Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 120 units of BD PosiFlush SF Saline Flush Syringes used in pediatric kits because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1993-2020·2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the…
Category
Medical Device
Distribution
Distributed nationwide