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 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.
Minimum severity
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.
Busse Hospital Disposables is recalling its SS 4.5MM Pellet Insertion Tray nationwide due to uncertainty regarding the adequacy of the validation of the manufacturing test methods used.
Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.
Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.
Baxter Healthcare is recalling in-line ventilator adaptors (Optimus Handset 2 module) used in home care. The devices may cause reduced oxygenation or barotrauma when used with Volara systems.
Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are recalled due to uncertainty about manufacturing test method validation.
Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.
Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.