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.
Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing a risk to patient health.
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
Medline is recalling medical convenience kits that contain plastic syringes with potential leaks, breakage, and other quality issues that may pose risks to patient health.
Medline is recalling convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.
Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.
Medline Industries is recalling multiple medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.
Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.
Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.
Medline is recalling medical convenience kits with plastic syringes affected by quality defects including leaks and breakage. The defective syringes may pose risks to patient safety during medical procedures.
Medline is recalling Convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality defects that may pose a risk to patient safety.
Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.
Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.
Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.