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
The Endo-Model Replacement Plateau implant is being recalled because the screw bushing may detach due to a longitudinal fracture, potentially compromising implant function.
Exactech is recalling 120 units of Equinoxe Ergo Modular Impactor Handles (Model 321-09-05) because the handle may be missing a cross-pin, a structural component that could compromise surgical function.
Medartis is recalling APTUS 2.5 TriLock Screws (Lot 25472432) due to a mix-up between 2.5mm and 2.8mm diameter screws. Using the wrong diameter screw could compromise proper surgical fixation.
Artelon FLEXBAND TWIST surgical augmentation devices failed bacterial endotoxin testing. The recall affects devices distributed nationwide and internationally; contact your healthcare provider if you received this device.
Covidien's Vital Sync remote patient monitoring systems may fail to transmit critical alarms from bedside monitors to the central monitoring platform, potentially delaying clinical alerts.
Altruan GmbH is recalling the Clearest Strep-A Cassette Test because the product has not been cleared by the FDA. The test detects group A streptococci in throat swab samples.
Exactech is recalling the Equinoxe Core Instrument Kit because the impactor handle may be missing a cross-pin, potentially affecting surgical instrument functionality and safety. Approximately 596 kits were distributed across the United States and internationally.
Some PROTEUS 235 proton therapy systems have a disabled safety feature that could fail to stop radiation beam delivery if an external gating device loses signal, potentially causing patient overexposure.
Boston Scientific is recalling EndoVive Safety PEG Kits due to open or compromised seals on included ChloraPrep Triple Swabsticks that could result in loss of sterility or drying of antiseptic solution.
When left open beyond 15 minutes, certain DxC 700 AU analyzers experience database errors causing system failure. The analyzer stops working and requires a service call to restore operation.
GEM PAK cartridges for the GEM Premier 5000 blood analyzer may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejections and potentially delaying test results.
Certain GEM Premier 5000 cartridges may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejection and delayed test results. Affected units were distributed worldwide.
Medline Medcrest surgical gowns may delaminate when laundered, risking surgical barrier failure and infection. The FDA has recalled 104,004 units distributed nationwide and internationally.
GEM PAK cartridges for the GEM Premier 5000 laboratory analyzer may experience increased Process Control Solution Not Detected errors during warm-up, causing cartridge ejection and operational disruption. The affected product includes 1,629 units distributed worldwide.
Waldemar Link is recalling the Endo-Model SL Connection Component orthopedic implant due to potential detachment of the plateau screw bushing from the shaft caused by longitudinal fracture. The recall affects 49 units distributed worldwide.
Instrumentation Laboratory is recalling GEM Premier 5000 cartridges that may eject during warm-up due to Process Control Solution Not Detected errors, potentially delaying diagnostic results. The issue affects 253 units distributed worldwide.
BD is recalling 204,000 units of 10mL non-sterile Luer-Lok syringes because Luer Slip syringes were mistakenly packaged in batches marked for Luer-Lok. The recall affects units distributed in California and Texas.
Medline Industries is recalling surgical drapes that may develop premature fabric delamination during laundering. This could delay patient care or allow surgical site contamination if the affected product is used.
Waldemar Link is recalling Endo-Model Replacement Plateau implants because the bushing could detach from the screw shaft due to a longitudinal fracture. This mechanical failure could compromise the implant's integrity.
Waldemar Link's Endo-Model Replacement Plateau knee implant is recalled because the bushing on the plateau screw could detach due to longitudinal fracture. Eight units with specific lot numbers were distributed globally.
Wondfo Streptococcal A At-Home Self-Test has been recalled nationwide because the product was not cleared by the FDA. Consumers should discontinue use immediately.
GEM Premier 5000 cartridges experience increased ejection errors during warm-up. The malfunction may delay test results and require manual cartridge replacement.
The CLARITY II Laser System by Lutronic is being recalled following reports of devices sparking and popping, which may burn patients during use. The recall affects 1,525 units distributed worldwide.
An implant connection component manufactured by Waldemar Link may experience bushing detachment due to a longitudinal screw fracture. The recall affects 31 units distributed in the United States and internationally.
Waldemar Link is recalling Endo-Model Replacement Plateau implants (Item 15-2836/11) due to potential bushing detachment from the screw shaft caused by longitudinal fracture. Seven units affected worldwide including the US. No injuries reported.