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

24951–24975 of 40397

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
SevereFDA (Devices)·Z-0639-2018·2018-02-28
Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error
Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.
Product
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-0584-2018·2018-02-28
Medtronic Viva CRT-D Recall for Possible Prevention of Therapy
Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0688-2018·2018-02-28
Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers
Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
Product
PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0682-2018·2018-02-28
Vygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns
Vygon is voluntarily recalling 200 units of 3-Way Standardbore Stopcocks because packaging adhesive issues may compromise product sterility.
Product
3-Way Standardbore Stopcock. Product Code: AMS-100.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0645-2018·2018-02-28
Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach
Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.
Product
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0671-2018·2018-02-28
Med Tec Protura Software Recalled for Pedestal Coordinate Errors
Med Tec Inc is recalling Protura software versions that may fail to update pedestal location data, potentially affecting treatment table movements.
Product
Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0650-2018·2018-02-28
Arrow International Recalls Multi Lumen Central Venous Catheterization Kits
Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.
Product
Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
Category
Medical Device
Distribution
Distributed nationwide

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24951–24975 of 40397