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
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.
BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.
O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.
Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.
Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.
Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.
Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.
FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.
Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.
Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.
Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.
Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.
CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.
Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.