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
CoolSeal Generator units (REF: CSL-200-50) may have a manufacturing defect preventing them from meeting electrical safety standards, potentially resulting in unintended energy delivery to patients.
Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.
A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.
Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.
ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.
Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.
Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.
Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.
Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.
Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
A limited number of Philips Respironics V60 ventilators were assembled with expired adhesive. If the adhesive fails, the ventilator could stop providing ventilation.
MEDLINE recalls Micro-Kill Bleach Germicidal Wipes due to out-of-specification low levels of sodium hypochlorite, the active disinfecting ingredient. Affected batches may have reduced effectiveness.
BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.
K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.