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 deaths or serious injuries are reported, 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

7401–7425 of 27393

HighFDA (Devices)·Z-2245-2023·2023-08-02
Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2215-2023·2023-08-02
Respiratory diagnostic panel fails to produce test results
Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.
Product
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapn
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2234-2023·2023-08-02
Laser fiber medical devices recalled for potential burn injury hazard
Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.
Product
Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2230-2023·2023-08-02
Laser Fiber Devices May Overheat and Cause Burns During Use
Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.
Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2023·2023-08-02
Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard
Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.
Product
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2023·2023-08-02
Hernia repair mesh balloon may not inflate during surgery
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
Product
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2023·2023-08-02
Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.
Product
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2023·2023-08-02
vRad PACS medical imaging system recalled for intermittent image display failures
Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.
Product
vRad PACS with Mammography
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2237-2023·2023-08-02
Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results
Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.
Product
Ringed DxI Reaction Vessels (RVs)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2023·2023-08-02
Trexo Device recalled due to electrical hazards and burn risk
Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.
Product
Trexo Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2227-2023·2023-08-02
Flexible Laryngeal Mask Airway Packs Lack Required Expiration Date Labels
Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.
Product
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2023·2023-08-02
Surgical mesh inflation malfunction in Ventralight ST hernia repair device
Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.
Product
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU On
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2023·2023-08-02
Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery
A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.
Product
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2238-2023·2023-08-02
FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length
The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.
Product
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2228-2023·2023-08-02
Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk
Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.
Product
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2023·2023-08-02
Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component
Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.
Product
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2023·2023-08-02
Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard
Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.
Product
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2233-2023·2023-08-02
Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component
Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.
Product
Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2016-2023·2023-07-26
Olympus Bronchovideoscope Recalled for Endobronchial Combustion Risk
Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.
Product
Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2152-2023·2023-07-26
Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2115-2023·2023-07-26
Impella CP Blood Pump Recalled for Blade Destruction From Stent Interaction
Abiomed's Impella CP cardiac pump can be damaged by interaction with replacement heart valves, potentially causing blood clots. The FDA classified this as a Class I recall of 9,252 units worldwide.
Product
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2151-2023·2023-07-26
Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown
Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2011-2023·2023-07-26
Olympus OES Bronchofiberscope Models Recalled for Combustion Risk During Laser Procedures
Olympus is recalling OES Bronchofiberscope models due to reports of combustion during laser procedures. This poses a serious burn injury risk to patients.
Product
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2015-2023·2023-07-26
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 Recalled Due to Combustion Risk
Olympus BRONCHOVIDEOSCOPE Model BF-Q170 is recalled nationally due to complaints of endobronchial combustion during therapeutic laser procedures, classified as FDA Class I.
Product
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2013-2023·2023-07-26
Olympus Bronchoscope Recall: Risk of Combustion During Laser Procedures
Olympus is recalling 9 bronchoscopes (Models BF-P150 and BF-1T150) due to complaints of endobronchial combustion during therapeutic laser procedures. The defect could cause fire and serious burn injuries.
Product
Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

7401–7425 of 27393