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
Peter Lazic GmbH's D-Clip Standard/Mini Applier is being recalled after a customer complaint that the device failed to release the clip during surgery, with the applier remaining attached to the clip.
Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.
Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.
FDA has recalled the D-Clip Standard/Mini Applier due to reports that the device failed to release the clip and remained attached during surgical use, creating a risk of surgical complications.
The FDA is advising on label interpretation for the SPII Model Lubinus hip prosthesis stem to prevent confusion during surgery. Two complaints prompted additional guidance on carton label size and type columns.
Baxter Healthcare is recalling STERIS Boot Assembly traction devices due to an incorrectly oriented locking pin that may cause the boot to detach during surgery, posing patient safety risks.
Baxter Healthcare recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapters due to potential leaks in the drip chamber. The recall affects 26,592 units distributed nationwide.
Waldemar Link is recalling SPII Model Lubinus Long Stem Prosthesis XL Neck implants due to carton labeling that could be misinterpreted during surgery. Clearer guidance is being provided to prevent surgical misapplication.
A hip prosthesis stem was recalled due to ambiguous carton label guidance that could cause incorrect implant selection during surgery. The recall affects 382 units.
Siemens Healthcare's ADVIA Centaur EPO Assay (lots 53984040, 55443042) produces readings 35% lower than the WHO standard, failing to achieve its claimed reference interval. No illnesses reported, but diagnostic inaccuracy poses risk of wrong clinical decisions.
Shimadzu has recalled the Trinias Digital Angiography System due to a capacitor manufacturing issue that could cause abnormal display or system malfunction. No injuries have been reported.
Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.
A surgical clip applier from Peter Lazic Gmbh has been recalled after a reported failure to release the clip during surgery. The applier remained attached to the clip, potentially posing a safety risk during medical procedures.
Waldemar Link is clarifying labeling on 153 hip prosthesis units after complaints about ambiguous Size and Type information. The guidance aims to prevent potential misinterpretation during surgery.
Peter Lazic Gmbh is recalling 170 L-Aneurysm Clip TITANIUM Paddle-Clips distributed in Maine due to incorrect blue coloring instead of blank.
Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.
Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.
Peter Lazic Gmbh is recalling 51 titanium aneurysm clip paddle clips because the clips are colored blue when they should be blank.
Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits because they contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist. Approximately 10,808 units have been distributed worldwide.
Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits containing a sterile pre-filled syringe that was recalled by Nurse Assist. Approximately 53,126 units were distributed worldwide.
Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.
Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.
Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 internationally.
Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.