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 240 Halyard EP Lab packs over the potential for an incomplete seal on the header bag.
Dough-To-Go is recalling 3,486 cases of Linzer Hearts Baked Cut Out Cookies over undeclared milk and FD&C Blue #1.
Hollandia Dairy is recalling 22,700 half-pint units of 100% Appleberry Juice contaminated with the cleaning solution peracetic acid. The product went to schools in southern California.
DICOM Grid is recalling 924 units of Intelerad InteleShare software because a bug can produce inaccurate length measurement tool values that could lead to misdiagnosis.
Rocket Medical is recalling 635 Rocket 12Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.
Rocket Medical is recalling 240 Rocket 12Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.
Medline is recalling 53 sterile Kelly forceps because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.
Medtronic MiniMed is recalling 8,251 units of the InPen App for Android because reinstalling the app deletes the notification override permission, so audible and vibratory alerts are not received.
Golden State Medical Supply is recalling 2,472 bottles of Baclofen Tablets USP, 10 mg, over the presence of foreign tablets or capsules.
Abbott Laboratories is recalling 11,653 Alinity ci-series System Control Modules because software versions 3.6.1 and lower could lead to erroneous results for multiple analytes.
AVID Medical is recalling 42 Halyard General Laparoscopy Packs over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 56 Halyard Head and Neck Trays over the potential for an incomplete seal on the header bag.
Celebration Herbals is recalling 1,226 retail units of Senna Leaf Herbal Tea over possible Salmonella.
Medline is recalling 56 sterile operating room scissors because weak packaging seals may result in a breach of sterility and an increased risk of infection if the product is used.
AVID Medical is recalling 300 Halyard Midtown General Arteriogram trays over the potential for an incomplete seal on the header bag.
Rocket Medical is recalling 110 Rocket 18Fg Seldinger Catheters with Safety Guard because the instructions and kit labeling contain misleading statements that can lead to improper securing.
Rocket Medical is recalling 840 Rocket 16Fg Seldinger Catheter Procedure Trays because the instructions and kit labeling contain misleading statements that can lead to improper securing.
Cepheid is recalling 4,032 Xpert BCR-ABL Ultra test kits because specimens with an elevated white blood cell count above 30,000 cells may cause inaccurate results.
Shata Traders is recalling 145 boxes of Chef brand 24cm Milk Pans after the products were found to contain leachable lead levels of 3.00 mg/L.
DSAART is recalling 35 AART Calf Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Novocol Pharmaceutical of Canada is recalling 40 cartons of Cook-Waite Carbocaine 3% mepivacaine injection over a defective container with cracked or broken cartridges.
DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Smith & Nephew is recalling 168 BIOSURE HA Screws, 6mm x 20mm, due to a labeling error on the affected lot.
Novocol Pharmaceutical of Canada is recalling 1,636 cartons of OraVerse (Phentolamine Mesylate) Injection over a defective container with cracked or broken cartridges.