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.

36776–36800 of 50504

HighFDA (Devices)·Z-0667-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products
MWT Materials, Inc. is recalling 15 Accusorb MRI radio frequency shielding blankets and body-part covers. The products may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0645-2016·2016-01-27
Cyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays
Cyberonics is recalling 29 Model 106 VNS Therapy AspireSR Generators due to delays in heartbeat sensing and potential decreased battery longevity.
Product
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0684-2016·2016-01-27
Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise
Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.
Product
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0669-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Leg Wraps Due to Overheating Risk
MWT Materials, Inc. is recalling 18 Accusorb MRI Leg Wraps because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2016·2016-01-27
Rymed InVision-Plus IV Connector Recall Due to Cracking Risk
Rymed Technologies is recalling 46,600 InVision-Plus CS Needleless IV Connectors because the female luer component may crack during use.
Product
InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0659-2016·2016-01-27
Cyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure
Cyberonics is recalling 4,935 VNS Therapy AspireSR Generators worldwide after three reports of device resets that disabled stimulation output.
Product
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0666-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk
MWT Materials, Inc. is recalling six Accusorb MRI Breast Shields because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·16V041000·2016-01-27
Newmar Recalls 2016 Dutch Star and Ventana for Incorrect Tire Label
Newmar is recalling 283 model year 2016 Dutch Star and Ventana vehicles because an incorrect tire inflation label could lead to overinflation and tire failure.
Product
NEWMAR — NEWMAR DUTCH STAR, VENTANA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·16083·2016-01-27
LocknCharge iQ10 Charging Stations Recalled for Electrical Shock Hazard
LocknCharge is recalling iQ10 charging stations due to a defective USB hub that can cause electrical shock. Consumers should stop using the units and contact the company for a free replacement.
Product
Charging stations
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2016·2016-01-27
Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise
Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.
Product
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0683-2016·2016-01-27
IBA Dosimetry Lift Table Recalled for Uncontrolled Movement Risk
IBA Dosimetry GmbH is recalling Lift Table Type 4320 units because they may move up in an uncontrolled manner when connected to power.
Product
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0682-2016·2016-01-27
GE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect
GE Medical Systems is recalling 240 anesthesia device service kits because a drive gas check valve could become stuck open, potentially causing excessive pressure in the patient breathing circuit.
Product
Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0514-2016·2016-01-27
Yoli Inc. Recalls Roasted Pumpkin Seeds Due to Undeclared Wheat
Yoli Inc. is recalling roasted pumpkin seeds with salt because the product contains undeclared wheat, a major food allergen.
Product
Roasted pumpkin seeds with salt in a clear plastic bag with a yellow and red label attatched.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0664-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk
MWT Materials, Inc. is recalling 31 Accusorb MRI arm sleeves distributed in New York and Massachusetts because they may overheat and injure patients when not used correctly.
Product
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0675-2016·2016-01-27
Rymed InVision-Plus IV Connectors Recalled for Cracking Risk
Rymed Technologies is recalling InVision-Plus IV connectors because the female luer component may crack during use.
Product
InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling Accusorb MRI MAC7030 shielding blankets and covers because they may overheat and cause patient injury when not used correctly.
Product
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0513-2016·2016-01-27
Eaton Farm Peanut Butter Bar Recalled for Soy Allergen Mislabeling
Eaton Farm Confectionaries is recalling Peanut Butter Lust Bars because the packaging lists 'Lecithin' without specifying it contains soy, a major allergen.
Product
Peanut Butter Lust Bar, Net weight 2 ounces, UPC: 1425361001
Category
Food
Distribution
4 states
HighFDA (Drugs)·D-0583-2016·2016-01-27
Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets
Pine Pharmaceuticals is recalling specific lots of Bevacizumab syringes for intravitreal use because they contain silicone oil microdroplets.
Product
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
HighCPSC·16724·2016-01-27
Lunera Recalls Helen GX23 LED Lamps Due to Fire and Shock Hazards
Lunera is recalling approximately 60,000 Helen GX23 LED lamps because they can overheat, posing fire, burn, and electric shock hazards. No injuries have been reported.
Product
Helen GX23 LED lamps
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0668-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Blankets
MWT Materials, Inc. is recalling 14 Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.
Product
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2016·2016-01-27
GE Healthcare Aestiva 7900 Ventilator Recall for Stuck Valve Risk
GE Medical Systems is recalling two Aestiva 7900 ventilators because a stuck valve could cause excessive pressure and barotrauma.
Product
GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0679-2016·2016-01-27
GE Healthcare Aestiva MRI Ventilator Recalled for Valve Defect
GE Medical Systems is recalling 84 Aestiva MRI anesthesia systems because a drive gas check valve may become stuck open, potentially causing excessive pressure in the patient breathing circuit.
Product
GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0573-2016·2016-01-27
Freedom Pharmaceuticals Recalls Baclofen Powder Due to Foreign Substance
Freedom Pharmaceuticals is recalling specific lots of Baclofen USP powder because of the presence of a foreign substance.
Product
Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d)…
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·16V042000·2016-01-27
Bluecar Recalls 2016 Models for Power Train Software Shutdown Risk
Bluecar is recalling 2016 models because power train software may shut down power to the vehicle, increasing the risk of a crash.
Product
BLUECAR — BLUECAR BLUECAR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0670-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Large Torso Wrap Due to Overheating Risk
MWT Materials, Inc. is recalling five units of Accusorb MRI Large Torso Wraps because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide