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

8676–8700 of 13652

CriticalFDA (Devices)·Z-2219-2023·2023-08-02
Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk
Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.
Product
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2221-2023·2023-08-02
Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk
Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
Product
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2223-2023·2023-08-02
LINEAR intra-aortic balloon catheter introducer dilator fracture risk
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Product
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2216-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion
The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.
Product
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2218-2023·2023-08-02
Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion
Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.
Product
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2222-2023·2023-08-02
Intra-aortic balloon catheter recall due to introducer dilator fracture risk
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
Product
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc I
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2217-2023·2023-08-02
Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk
The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.
Product
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2220-2023·2023-08-02
MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
Product
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2142-2023·2023-08-02
Hamilton C3 ventilator software anomaly may cause unexpected device stoppage
A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.
Product
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2139-2023·2023-08-02
HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown
Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.
Product
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2140-2023·2023-08-02
HAMILTON T1 Ventilator software defect may cause unexpected shutdown
Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.
Product
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2141-2023·2023-08-02
Hamilton C2 Ventilator recalled for software anomaly causing loss of function
FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.
Product
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Category
Medical Device
Distribution
0 states
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-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-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-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-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-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-2239-2023·2023-08-02
Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk
Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.
Product
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
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-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-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-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

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8676–8700 of 13652