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
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.
Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.
King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.
Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.
Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.
Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device sterility.
Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange after discovery that the solution can change color during use, resulting in out-of-specification fluorescent staining results.
King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.
King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.
Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.
Smith & Nephew is recalling a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.
Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.
Datex-Ohmeda's Aisys CS2 anesthesia machine may pose a risk if a patient breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet port. Ninety-two units worldwide are affected in this FDA Class I recall.
Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.
Baxter Healthcare recalls Life2000 Ventilators due to potential Low Gas Pressure alarm failure. The alarm may not activate if the gas source isn't connected before therapy begins.
Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.
Datex-Ohmeda Aisys anesthesia machines may allow patient breathing circuits to be incorrectly connected to the Auxiliary Common Gas Outlet, potentially affecting ventilation during anesthesia. Approximately 4,790 units worldwide are affected.
Datex-Ohmeda is recalling 20,097 Aespire 7100 series anesthesia machines because a patient breathing circuit can be mistakenly connected to the wrong outlet (ACGO port) instead of the intended connection point.