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

13101–13125 of 27500

HighFDA (Devices)·Z-2842-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling specific Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2834-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2896-2020·2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz Endoscopy is recalling 2,668 flexible intubation video endoscopes to provide updated sterilization instructions and prevent incomplete sterilization.
Product
Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2866-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2851-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2894-2020·2020-09-02
Karl Storz Flexible DCI Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 463 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
Product
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2852-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2857-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2892-2020·2020-09-02
Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates
Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.
Product
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2862-2020·2020-09-02
FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2893-2020·2020-09-02
Karl Storz Flexible Intubation Fiberscope Recall for Sterilization Instructions
Karl Storz is recalling 650 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid patient infection.
Product
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2836-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2840-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers kits distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2835-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling 32,855 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2878-2020·2020-09-02
Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results
Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.
Product
VITROS XT3400 Chemistry System, Product code 6844458
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2841-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected devices were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2891-2020·2020-09-02
Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions
Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.
Product
Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2855-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2884-2020·2020-09-02
Magstim Recalls Neurosign V4 Intraoperative Nerve Monitors Due to Cable Damage Risk
The Magstim Company Limited is recalling 49 Neurosign V4 Intraoperative Nerve monitors because cable manipulation may damage internal construction.
Product
Neurosign V4 Intraoperative Nerve monitor family of devices.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2881-2020·2020-09-02
Klarity Vacuum Bags Recalled for Inadequate Vacuum Retention During Radiation Therapy
Klarity Medical Products LLC is recalling 111 vacuum bags used for patient positioning during radiation therapy because they may not hold a vacuum adequately for the required treatment time.
Product
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2820-2020·2020-09-02
89 North LDI Laser Firmware Recall for Safety Interlock Defect
89 North is recalling 188 LDI laser units worldwide due to a firmware defect that allows laser emission to continue when safety interlocks are opened.
Product
LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2906-2020·2020-09-02
Neurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect
Neurovision is recalling Cobra x5 EMG endotracheal tubes because the electrode insulation may soften and damage, potentially stopping EMG signal transmission.
Product
Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2020·2020-09-02
Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
Product
ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2907-2020·2020-09-02
Neurovision Cobra x5 EMG ET Tube Recalled for Insulation Softening
Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
Product
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2845-2020·2020-09-02
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling 6,111 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.
Product
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Category
Medical Device
Distribution
Distributed nationwide

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13101–13125 of 27500