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

10526–10550 of 40095

HighFDA (Devices)·Z-1218-2023·2023-03-15
CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions
St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.
Product
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1217-2023·2023-03-15
Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration
Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.
Product
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1232-2023·2023-03-15
Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks
Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.
Product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2023·2023-03-15
Monaco RTP System software may calculate radiation therapy doses inaccurately
Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1213-2023·2023-03-15
Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
Product
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2023·2023-03-15
CardioMEMS PA Sensor models affected by radio-frequency range at high elevations
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2023·2023-03-15
CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2023·2023-03-15
Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
Product
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1228-2023·2023-03-15
Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.
Product
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2023·2023-03-15
TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1231-2023·2023-03-15
Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy
Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2023·2023-03-15
Cardiosave Rescue IABP Helium Regulator Failures May Impair Function
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1223-2023·2023-03-15
CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations
Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.
Product
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2023·2023-03-15
BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.
Product
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2023·2023-03-15
Dental anaerobic glue recalled for incorrect expiration date labeling
Preat Corp is recalling 652 units of PREAT NOBIL GRIP dental adhesive due to incorrect expiration dates on product labels. Consumers should verify lot numbers and contact the manufacturer.
Product
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1215-2023·2023-03-15
epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy
Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.
Product
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1140-2023·2023-03-08
Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk
Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.
Product
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1141-2023·2023-03-08
Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk
Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.
Product
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1142-2023·2023-03-08
Life2000 Ventilator poses oxygen desaturation risk with oxygen concentrators
The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.
Product
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1139-2023·2023-03-08
Life2000 Ventilator System Recall: Risk of Patient Desaturation
Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.
Product
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1205-2023·2023-03-08
Sit to Stand STS500 Patient Lift Recalled Due to Loose Boom Fasteners
Med-Mizer is recalling 37 units of the Sit to Stand STS500 Patient Lift due to risk of boom pivot failure caused by a loose securing nut and unsecured bolt on the boom flange.
Product
Sit to Stand STS500 Patient Lift
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1182-2023·2023-03-08
Custom Suture Packs recalled due to sterile barrier breach risk
Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1183-2023·2023-03-08
Surgical Mesh Recalled Due to Incorrect Collagen Film Placement
Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.
Product
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1169-2023·2023-03-08
Orthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging
Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2023·2023-03-08
CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.
Product
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide

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10526–10550 of 40095