Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
AVID Medical is recalling Halyard TOTAL KNEE kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site, causing local or foreign body reactions.
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.
AVID Medical is recalling Halyard shoulder surgical kits due to loose metal flakes that could detach and enter surgical sites. Metal debris could cause local or foreign body reactions.
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.
Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.
AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.
AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.
Cipla USA is recalling Lanthanum Carbonate Chewable Tablets (1000mg) distributed nationwide due to complaints of crushed and broken tablets that fail manufacturing specifications.
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.
AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.
AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.
Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.
MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.
AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.
The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.
AVID Medical recalls Halyard TAH-BUNDLE medical kits with sponge forceps and towel clamps. Loose metal flakes may detach and enter surgical sites, potentially causing local or foreign body reactions.
AVID Medical is recalling Halyard VAG hysterectomy instrument bundles due to loose metal flakes on surgical instruments that could contaminate surgical sites.
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.