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

15676–15700 of 27471

SevereFDA (Devices)·Z-1747-2019·2019-06-26
GE Healthcare Recalls Optima PET/CT Systems Due to X-Ray Exposure Hazard
GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.
Product
Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2019·2019-06-26
GE Healthcare Recalls Discovery PET/CT 710 Systems Due to Table Stop Defect
GE Healthcare is recalling 1,113 Discovery PET/CT 710 systems because the table may stop moving without stopping X-ray exposure.
Product
Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1766-2019·2019-06-26
Teleflex Recalls Sheridan Novaplus Endotracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Product
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2019·2019-06-26
Stryker Recalls Endotrac Hook/Triangle Blade Kits Due to Seal Integrity
Stryker GmbH is recalling 447 Endotrac ECTR Hook/Triangle Blade Kits because the sterile bag seal may be compromised, potentially affecting sterility.
Product
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2019·2019-06-26
GE Healthcare Recalls Discovery PET/CT 610 Systems Due to X-Ray Safety Issue
GE Healthcare is recalling 1,113 Discovery PET/CT 610 systems because the table may stop moving while X-ray exposure continues.
Product
Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1762-2019·2019-06-26
Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes Due to Disconnection Risk
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
Product
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1842-2019·2019-06-26
Ethicon Recalls Ethibond Excel Polyester Sutures Due to Endotoxin Risk
Ethicon, Inc. is recalling specific lots of Ethibond Excel polyester sutures because raw materials used in manufacturing may contain high endotoxin levels.
Product
ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1837-2019·2019-06-26
CIVCO Solstice SRS Immobilization System Recalled for Potential Movement
Med Tec Inc is recalling 28 units of the CIVCO Solstice SRS Immobilization System because the device may move during patient setup or treatment.
Product
CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1760-2019·2019-06-26
Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm Sheridan connector may become disconnected from the endotracheal tube.
Product
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2019·2019-06-26
GE Healthcare Recalls Vscan Extend Ultrasound Devices Due to EF Calculation Bias
GE Healthcare is recalling 119 Vscan Extend ultrasound devices because the LVivo EF app may overestimate ejection fraction values, potentially affecting clinical assessments.
Product
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2019·2019-06-26
Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Safety Lock Knob
Cook Inc. is recalling Zenith Alpha Abdominal Endovascular Grafts that may contain a damaged gray safety lock knob, which could prevent full deployment of the graft.
Product
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1761-2019·2019-06-26
Teleflex Recalls Hudson RCI Sheridan Endotracheal Tubes Due to Disconnection
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan EZ-ENDO endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Product
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2019·2019-06-26
Teleflex Recalls Hudson RCI Sheridan Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
Product
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1705-2019·2019-06-19
Edwards Lifesciences Recalls IntraClude Intra-Aortic Occlusion Devices Due to Balloon Rupture Risk
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices because the balloon may rupture during cardiopulmonary bypass, potentially obscuring the operative site and requiring a change in surgical strategy.
Product
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1752-2019·2019-06-19
GE Healthcare Recalls Proteus XR/a Radiographic Systems Due to Monitor Fall Risk
GE Healthcare is recalling 825 Proteus XR/a radiographic systems because a monitor fell off its wall mount due to product aging.
Product
Proteus XR/a The Proteus XR/a radiographic system offers the flexibility to choose a configuration based upon your specific requirements. The system provides exceptional image quality, high frequency X-ray generation, easy patient positioning, intuitive operator control and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2019·2019-06-19
GE Healthcare Recalls Silhouette VR Systems Due to Monitor Mount Failure
GE Healthcare is recalling 825 Silhouette VR systems because a CRT monitor fell off its wall mount due to product aging.
Product
Silhouette VR This fully integrated system offers intuitive controls with advanced applications for maximum performance all in a space-saving design.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1775-2019·2019-06-19
Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy
Conformis, Inc. is recalling 128 iTotal Hip Replacement System stems due to a 3mm discrepancy between approved and manufactured neck/head lengths.
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2019·2019-06-19
Skytron Integrity 270 Steam Sterilizer Recalled for Weld Fatigue
Skytron is recalling five Integrity 270 Steam Sterilizers because the weld attaching the air heater assembly has shown signs of fatigue or failure.
Product
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2019·2019-06-19
GE Healthcare Recalls Prestilix 1600X Digital Radiology Systems
GE Healthcare is recalling 825 Prestilix 1600X digital radiology systems because a monitor fell off its wall mount due to product aging.
Product
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1774-2019·2019-06-19
Medtronic InterStim System Recall for Unexpected Stimulation Increase
Medtronic is recalling InterStim System kits due to a potential for unexpected stimulation increases during programming with the A10 Clinician Application.
Product
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1778-2019·2019-06-19
Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse
Maquet Cardiovascular is recalling 40 Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.
Product
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1777-2019·2019-06-19
Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse
Maquet Cardiovascular is recalling four Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.
Product
Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1780-2019·2019-06-19
Cook Inc. Recalls Neff Percutaneous Access Sets Due to Sterility Concerns
Cook Inc. is recalling 97 Neff Percutaneous Access Sets because they may have been manufactured without a bottom seal, compromising sterility. No US distribution occurred.
Product
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1781-2019·2019-06-19
GE Centricity PACS-IW Recall for Potential Missing Image Series
GE Healthcare is recalling 620 units of Centricity PACS-IW software because image series may be missing from exams without a warning.
Product
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1769-2019·2019-06-19
Terumo Electronic Patient Gas System Recalled for Control Slider Failure
Terumo is recalling 72 Electronic Patient Gas Systems used in cardio-pulmonary bypass because a fault disables control sliders, forcing use of local knobs.
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide

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15676–15700 of 27471