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
Windstone Medical Packaging is recalling 60 custom surgical kits containing a recalled catheter component due to a potential sterile barrier breach.
North Star Imaging is recalling three Model X-7000 industrial cabinet x-ray systems due to a discovered low-level radiation leak.
Teleflex Medical is recalling 13,710 units of the Auto Endo5 Automatic Hem-o-lok Clip Applier because clips may misalign, jam, or fall out of the device.
Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.
Lima is recalling 20 Delta Cup Beater Positioner units in the US due to suboptimal welding that may reduce mechanical strength and cause breakage during use.
Sorin Group USA is recalling a specific lot of FlexFlow Venous Cannulas because they are sharper or pointier than expected.
Encore Medical is recalling 840 units of Cobalt MV Bone Cement because the sterile Tyvek packaging seal may be lost, potentially compromising sterility.
Boston Scientific is recalling 12 Resonate EL ICD DR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
Epimed International is recalling 500 units of RX-2 COUDE Epidural Needles due to a potential incomplete seal that may impact sterility.
Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.
Encore Medical, Lp is recalling Cobalt HV with Gentamicin bone cement because the sterile Tyvek packaging may have lost its seal, potentially compromising sterility.
Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.
Teleflex is recalling specific Percuvance surgical instruments because the tool tip jaws may break, causing fragments to fall off during use.
Biosense Webster is recalling THERMOCOOL SF NAV catheters because a system alert may cause physicians to ablate in unintended areas.
Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Biosense Webster is recalling 64 THERMOCOOL SMARTTOUCH catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Bios S.r.l. is recalling 167 THERMI250 Radiofrequency Systems because they may continue to emit RF energy after the PAUSE button is pressed.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.
Biosense Webster is recalling THERMOCOOL catheters because they may trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.
Smiths Medical is recalling CADD Medication Cassette Reservoirs because some units may have been manufactured with an incorrect pressure plate.
OriGen Biomedical is recalling 180 units of Reinforced Dual Lumen Catheters because the extension tube may separate from the hub, causing patient injury.
MicroPort Orthopedics is recalling 48 sterile Schanz screws due to an inadequate pouch seal that could compromise sterility and lead to infection.
FDA requested the removal of specific energy treatment settings from 12 Ablatherm ultrasound systems in the U.S. pending clinical data evaluation.
Bard Peripheral Vascular Inc is recalling 110,550 Max-Core Disposable Core Biopsy Instruments due to increased complaints of failure to prime, fire, or obtain samples.