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.

23151–23175 of 50435

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
HighFDA (Devices)·Z-1985-2020·2020-05-20
Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - 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-1935-2020·2020-05-20
Stryker Power-PRO TL Ambulance Cots Recalled for Crash Test Non-Compliance
Stryker is recalling 34 Power-PRO TL ambulance cots in the UK because they may not meet the crash test standard BS EN 1789.
Product
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1966-2020·2020-05-20
Magstim Recalls Rapid2 Stim Interconnecting Cables Due to Potential Failure
The Magstim Company Limited is recalling 71 Rapid2 PSU Stim Interconnecting Cables because the high-voltage cable may fail. The recall covers units distributed worldwide.
Product
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1978-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes
Access Scientific LLC is recalling 30 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 8cm Quick Kit. REF/UDI / 94114/10859821006220 - 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-1975-2020·2020-05-20
Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes
Access Scientific LLC is recalling 6,066 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 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - 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-1940-2020·2020-05-20
Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents
Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.
Product
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system.…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1984-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
Product
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - 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-1987-2020·2020-05-20
Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures
Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - 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-1990-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.
Product
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2020·2020-05-20
Cardiac Assist Recalls TandemLung Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling two TandemLung Kit units because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - 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-1952-2020·2020-05-20
Cardiac Assist Recalls TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 46 TandemHeart ProtekDuo Kits due to an assembly error that may cause failure to prime.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - 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-1979-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters because holes in the packaging compromised sterility.
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - 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…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·20V288000·2020-05-20
Vac-Tron Vacuum Excavator Trailers Recalled for Lighting and Reflectivity Defects
Vac-Tron is recalling 2016-2020 vacuum excavator trailers because improper lamp positioning and missing reflectors may reduce visibility and increase crash risk.
Product
VAC-TRON — VAC-TRON LP MINI 373 GT, LP MINI 373 DT, CS 870 GT, CS 873 GT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2020·2020-05-20
Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 110 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 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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-1951-2020·2020-05-20
Cardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error
Cardiac Assist, Inc. is recalling 38 TandemHeart ProtekDuo Kits because an assembly error may prevent the pump from priming.
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - 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
HighNHTSA·20V290000·2020-05-20
Vac-Tron Vacuum Excavator Trailers Recalled for Lighting Defects
Vac-Tron is recalling 2016-2020 vacuum excavator trailers because front clearance lamps may be positioned improperly and reflectors may be missing, increasing crash risk.
Product
VAC-TRON — VAC-TRON LP 1273 XDT, CS 1270 GT, CS 1273 GT, CS 870 GT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1967-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
Product
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - 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-1956-2020·2020-05-20
Merit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error
Merit Medical Systems is recalling 15 Custom Sheath Introducer Kits because they were incorrectly labeled and contained the wrong sheath assembly.
Product
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2007-2020·2020-05-20
Edwards Lifesciences Recalls Sterile Oxymetry Oligon Catheter Kits
Edwards Lifesciences is recalling 597 sterile catheter kits because their packaging was compromised, potentially affecting sterility.
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1963-2020·2020-05-20
DeRoyal Sterile Custom Kits Recalled Due to Packaging Holes
DeRoyal Industries is recalling sterile custom kits packaged with BD PosiFlush syringes because holes in the packaging may compromise sterility.
Product
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-6209.03 b. H* Vein Pack, 89-6209.04 c. PICC Line Tray Pgybk, 89-6150.12 d. Umbilical Arterial Cath, 89-9370.01 e.…
Category
Medical Device
Distribution
8 states
HighNHTSA·20V280000·2020-05-18
Mitsubishi Recalls Outlander Models Due to Second-Row Seat Belt Assembly Defect
Mitsubishi is recalling 2019-2020 Outlander and 2019 Outlander PHEV vehicles because the right-side second-row seat belt may be assembled incorrectly, potentially failing to restrain occupants in a crash.
Product
MITSUBISHI — MITSUBISHI OUTLANDER, OUTLANDER PHEV
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·20V277000·2020-05-15
Yamaha Recalls 2015-2018 XC155 Scooters Due to Cylinder Head Nut Issue
Yamaha is recalling 2015-2018 XC155 scooters because cylinder head nuts may loosen, causing coolant to foul the spark plug and potentially leading to engine stalling.
Product
YAMAHA — YAMAHA SMAX, XC155F
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·20744·2020-05-14
John Deere Recalls Broom Attachment Kits Due to Missing Manual
John Deere is recalling 60-inch broom attachment kits for compact utility tractors because they lack the required Operator's Manual, posing an injury hazard.
Product
Attachment Kits for John Deere 60-inch Brooms
Category
Consumer Product
Distribution
Distributed nationwide