Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

22301–22325 of 27663

SevereFDA (Devices)·Z-0677-2016·2016-01-27
GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.
Product
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0663-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury when not used correctly.
Product
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0671-2016·2016-01-27
MWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.
Product
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0598-2016·2016-01-27
Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy
Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.
Product
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0685-2016·2016-01-27
Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise
Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.
Product
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
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
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 (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 (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 (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
HighFDA (Devices)·Z-0681-2016·2016-01-27
GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.
Product
GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult).…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0587-2016·2016-01-20
Thornhill Research Recalls MOVES System Lithium Polymer Batteries
Thornhill Research Inc is recalling 178 MOVES System Lithium Polymer Batteries because they may become unresponsive after storage and remain perpetually enabled.
Product
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0586-2016·2016-01-20
Thornhill Research Recalls MOVES Emergency Ventilators Due to Battery Defects
Thornhill Research Inc. is recalling 83 MOVES System emergency ventilators because the batteries may become unresponsive after storage and remain perpetually enabled.
Product
MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent…
Category
Medical Device
Distribution
1 state

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22301–22325 of 27663