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
AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.
IonoStar Plus dental cement capsules contain an incorrect plunger due to a manufacturing error. The defect prevents proper curing of the cement, making the product unsuitable for use.
Ionolux dental cement capsules may contain incorrect plungers that prevent proper curing. Affected batches distributed in the US and internationally should not be used.
Philips Azurion 7 imaging systems may experience power loss due to a potential short circuit in the power inverter, risking delays or termination of diagnostic and surgical procedures.
Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.
Olympus Corporation of the Americas is recalling ESG PK Cutting Forceps because the jaw may fracture during pre-procedure inspection or during the procedure, posing a potential injury risk.
Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.
B. Braun Medical recalls 3,890 PERIFIX epidural trays nationwide due to filter straws with incompatible neuraxial connectors instead of standard Luer connectors.
Philips Allura Xper fluoroscopic X-ray systems may experience memory module failures that cause the system to stop functioning and prevent imaging. This malfunction could delay critical medical procedures.
Synapse Cardiology PACS software versions 7.0–7.3.0 may calculate left ventricle mass incorrectly, potentially leading to misdiagnosis or wrong treatment plans. Thirteen units have been distributed in the US and Israel.
FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.
Patterson Procedure Earloop Masks (ASTM Level 3, blue) are being recalled because units were produced on non-validated equipment. The recall affects 180 cases with lot numbers 2339 and 2342, distributed across six states.
A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.
Boston Scientific is recalling EndoVive Replacement Button Kits due to sizing mislabeling that could cause undersizing and serious complications including tissue damage and sepsis.
AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.
3M is recalling the Specialty Blade Assembly (REF 9660) used with 3M Surgical Clippers worldwide due to burn risk if the blade overheats during operation. Approximately 52.8 million units affected across all lot codes.
B. Braun PERIFIX epidural kits contain filter straws with Neuraxial connectors instead of Standard Luer Connections, preventing proper assembly of the kits.
Philips is recalling 14 units of its Azurion 3 surgical imaging system due to a potential short circuit in the power inverter. The defect could cause the device to lose power and fail during surgical procedures.
3M recalled 764,580 Specialty Blade Assemblies for surgical clippers due to risk of burns from overheating. The blade can reach temperatures exceeding 77°C if left running improperly.
The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.
The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.
Medline is recalling 1.3 million units of bleach germicidal wipes due to stability concerns. Products labeled for 24-month shelf life are only safe and effective for 12 months.
W&H Surgical handpiece S-12 devices were incorrectly laser marked with '1:1' instead of the correct '1:2' during production. 160 units are affected.
The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.
GE Healthcare is recalling 1,410 neonatal incubators worldwide because bedside panels and portholes can appear closed while not properly latched. If impacted, they may fall open and fail to protect patients from falls.