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

24876–24900 of 40233

LowFDA (Devices)·Z-0771-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0755-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.
Product
Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0751-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and ink transfer to devices.
Product
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0754-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0807-2018·2018-03-07
Ortho Recalls VITROS Performance Verifier II Due to Stability Issues
Ortho Clinical Diagnostics is recalling VITROS Performance Verifier II Lot K4852 because it fails long-term stability requirements for the AST analyte when refrigerated.
Product
VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0691-2018·2018-03-07
CooperVision Recalls Biofinity XR Toric Contact Lenses Due to Labeling Error
CooperVision is recalling specific Biofinity XR Toric contact lenses because the primary blister labels incorrectly identify them as Biofinity Multifocal Toric.
Product
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0753-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0767-2018·2018-03-07
Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects
Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.
Product
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0758-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0768-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to enclosed devices.
Product
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0760-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0749-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0756-2018·2018-03-07
Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
Steris is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0766-2018·2018-03-07
Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration
Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Product
Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0583-2018·2018-02-28
Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0587-2018·2018-02-28
Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention
Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0642-2018·2018-02-28
Allen Medical Systems Recalls Radiolucent Surgery Spine Frames
Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.
Product
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0582-2018·2018-02-28
Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk
Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0588-2018·2018-02-28
Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk
Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.
Product
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0638-2018·2018-02-28
ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors
Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.
Product
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-0641-2018·2018-02-28
Allen Medical Bow Frame Recalled Due to Potential Base Cracking
Allen Medical Systems is recalling 161 Bow Frame Model A-70800 surgical platforms because the base may crack when patients are transferred onto the device.
Product
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0585-2018·2018-02-28
Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk
Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.
Product
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0586-2018·2018-02-28
Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0589-2018·2018-02-28
Medtronic Visia AF ICDs Recalled for Potential Therapy Failure
Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.
Product
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0640-2018·2018-02-28
GastriSail Gastric Positioning Device Recalled Due to Perforation Reports
FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.
Product
GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

24876–24900 of 40233