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
Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.
Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.
Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.
Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
Bruder Healthcare Company is recalling certain lots of Thermalon Sinus Compress due to potential mold and mildew growth from moisture exposure. The product was distributed in the US and Canada.
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.
Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.
Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.