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 Inc voluntarily recalled the DeRoyal TOTAL SHOULDER PACK (Lot 56658012, exp. 1/1/2024), affecting 30 kits distributed across 23 US states. The specific reason for recall is not disclosed in available FDA documentation.
DeRoyal Industries is recalling 90 ophtalmology procedure kits because they contain 3M Steri Drapes that have been recalled. The affected kits were distributed across multiple U.S. states.
DeRoyal Industries has voluntarily recalled 75 DeRoyal UNIVERSAL PACK kits (Ref 89-9558.03) distributed across 23 US states. The specific reason for the recall has not been disclosed in available documentation.
DeRoyal Industries Inc voluntarily recalled approximately 460 units of GEO-MED BIOPSY TRAY distributed across 23 US states. The specific reason for the recall is not disclosed in available FDA documentation.
DeRoyal TOTAL KNEE PACK surgical kits are being recalled as a Class II device recall. The specific reason for recall is not documented in available source records.
DeRoyal Industries is recalling 120 units of Biopsy Packpack medical devices distributed across 23 states. The specific reason for the recall is not disclosed in the FDA notice.
DeRoyal Industries is recalling 240 DeRoyal HEART PACK medical device kits (REF 89-8351.11). The specific reason for the recall is not disclosed in the FDA notice.
DeRoyal Industries is voluntarily recalling 51 units of the DeRoyal TOTAL HIP KIT (Lot 56187960 and 57031051) distributed to healthcare facilities across 23 US states.
DeRoyal Industries voluntarily recalled 75 units of its PACEMAKER ICD PACK (REF 89-10216.06, Lot 57898501) distributed across 23 US states on November 3, 2022.
DeRoyal Industries Inc voluntarily recalls 105 kits of DeRoyal Foot Pack (Lot 57899862, exp 3/1/2025) distributed across 23 U.S. states. Affected customers should contact the firm for recall instructions.
DeRoyal Industries voluntarily recalled 49 kits of the GEO-MED TOTAL KNEE PACK A & B distributed across 23 U.S. states. The specific reason for the recall is not detailed in the FDA notice.
DeRoyal MAJOR ORTHO PACK kits (Ref 89-9250.07) are being voluntarily recalled. The specific reason is not provided in the FDA notice. Affected lots were distributed across 23 U.S. states.
DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
DeRoyal Industries initiated a voluntary Class II recall of its Lumbar Fusion Pack (51 kits) distributed across 23 US states. The specific reason for the recall was not documented in available records.
Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.
Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
GREEN DAY PRODUCE is recalling enoki mushrooms (UPC 16430-69080) due to Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors in 12 states.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.