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 recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.
AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.
The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.
The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.
AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was distributed nationwide.
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 MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
AVID Medical is recalling Halyard SPINE surgical kits (Model EUOR004-02) due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could potentially enter a patient's surgical site, causing local or foreign body reactions.
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.
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 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.
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.
AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.
Philips Zenition 50 imaging systems may experience mains control unit fuse failure during startup or procedures. The defect could cause equipment malfunction.
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.