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.
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.
Minimum severity
Philips recalls Azurion imaging systems because the foot switch pedal may stick in the active position, causing unintended radiation emission. Facilities should stop using the systems and contact Philips for guidance.
ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.
Datascope Corp. is recalling 9,175 units of Cardiosave Rescue IABP devices because batteries will not charge if the console is not fully inserted into the hospital cart. Users were often unaware of this insertion requirement.
The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.
Datascope is recalling Cardiosave Hybrid intra-aortic balloon pumps due to reported temperature alarms that can cause loss of pumping function or unexpected standby mode. Users have reported these system failures in critical cardiac support devices.
Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.
Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.
Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
RayCare oncology software versions 5A, 5B, and 6A may fail to display medication allergy warnings under certain circumstances. Healthcare facilities could inadvertently prescribe medications patients are allergic to.
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.