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 EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.
FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.
The FDA is recalling 32 X-ray detector units due to a potential drive shaft failure that could cause uncontrolled detector movement. Affected units are distributed in 10 US states.
Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.
FDA recalls the Intelli-C X-Ray machine's left side suspended tabletop model due to potential drive shaft failure in the detector lift mechanism, which could cause uncontrolled detector movement.
Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.
Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.
Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.
Maquet Medical Systems USA recalls 24,250 QUADROX-iD Adult Oxygenators due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices during cardiopulmonary bypass surgery.
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or ischemia.
Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of infection, sepsis, or ischemia.
Maquet is recalling QUADROX-i Adult cardiopulmonary bypass oxygenators (Models HMO 70000-USA and HMO 71000-USA) due to packaging defects including holes, cracks, and improper placement of accessories that may compromise sterility.
Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.
Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing higher-than-expected revision rates compared to similar devices.
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.
SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.
Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
Windstone Medical Packaging is recalling Aligned Medical Solutions Hand Pack kits because light handle covers may detach during surgical procedures, potentially compromising the sterile field.
Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.