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.
DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.
DeRoyal Industries is recalling 27 kits of its Spinal Fusion Pack due to inclusion of recalled 3M Health Care Steri Drapes. The affected lots were distributed across 23 U.S. states.
DeRoyal Industries is voluntarily recalling 76 GEO-MED PODIATRY PACK kits distributed across 23 U.S. states. The specific reason for this Class II recall is not detailed in the public notice.
DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the notice.
DeRoyal has voluntarily recalled 117 TRACECART shoulder arthroscopy kits distributed across 23 U.S. states. No illnesses or injuries have been reported. The specific reason for the recall is not disclosed in available FDA documentation.
DeRoyal Industries initiated a voluntary recall of 12 kits of Lumbar Disc Pack medical devices distributed across 23 US states. Specific hazard details from the FDA are not available in the source data.
DeRoyal is recalling 336 TRACECART surgical kits distributed across 23 US states. This is a voluntary, Class II recall initiated by the manufacturer.
DeRoyal Industries voluntarily recalled 360 kits of its BIOPSY PACK (Lot 57686568) distributed across 22 U.S. states. The specific reason for the recall is not specified in available FDA documentation.
DeRoyal BASIC NEURO PACK procedure kits are recalled because they contain 3M Health Care Steri Drapes that were previously recalled. 108 kits were distributed across multiple US states.
DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.
DeRoyal Industries is voluntarily recalling 1,100 kits of pain tray devices distributed across 23 US states. The FDA classified this as a Class II recall.
DeRoyal Industries initiated a voluntary recall of 363 shoulder arthroscopy surgical packs. The specific reason for the recall was not disclosed in the notice.
Allison Medical recalls CarePoint 60 mL syringes due to green substance found on plungers. While the substance is nontoxic, its potential interaction with medications is unknown.
DeRoyal Industries Inc initiated a voluntary recall of 93 kits of the DeRoyal NEURO PACK affecting 23 U.S. states. The recall affects three lot numbers with March 1, 2025 expiration.
DeRoyal Industries has voluntarily recalled 304 kits of the BASIC NEURO PACK (REF 89-7523.16) across 23 states. The recall is ongoing.
DeRoyal Industries initiated a voluntary recall of 6 kits of its Lumbar Disc Pack medical device distributed across 23 US states. The specific reason for recall was not detailed in the notice.
DeRoyal Industries recalled 68 DeRoyal KIT HEART B PACK units (Class II, voluntary). The specific reason for the recall is not documented in the source.
DeRoyal Industries has voluntarily recalled 180 units of its Biopsy Pack (Lot 56842514, exp. 8/1/2026) following an FDA Class II classification. The product was distributed across 23 U.S. states.
DeRoyal Industries voluntarily recalled 1200 biopsy pack kits distributed across 23 U.S. states. The reason for the recall was not disclosed in available source material.
Camber Pharmaceuticals is recalling specific lots of Lacosamide oral solution due to out-of-specification p-Hydroxybenzoic Acid content. The recall affects multiple lot numbers distributed nationwide.
DeRoyal Industries voluntarily recalled 162 breast tray kits (REF 89-7033.07). The specific reason for the recall was not publicly disclosed.
DeRoyal Industries has recalled 192 kits of the DeRoyal GU Robotic Pack (Lot 57387066, expires 9/1/2026) distributed across 23 U.S. states. The FDA classified this as a Class II recall.
DeRoyal's GEO-MED ophthalmology procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Thirty kits were distributed across 23 US states.
DeRoyal Industries Inc recalled 243 SPINE PACK medical device kits distributed across 23 US states as a Class II FDA recall. The specific reason for the recall is not detailed in the available notice.
DeRoyal Industries initiated a voluntary recall of 552 units of its CATARACT PACK due to an unspecified defect. The FDA classified this Class II recall on December 15, 2022.