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.
MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.
Exactech is recalling 985 shoulder implant components due to nonconforming packaging that lacks a required oxygen barrier layer. The vacuum bags do not meet packaging specifications.
Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.
Covidien recalls its Auto Suture blunt tip trocar (OMS-T10BTS) due to potential seal disengagement when mesh products are used incorrectly, affecting approximately 18,048 units worldwide.
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
Exactech, Inc. is recalling 2,077 units of Equinoxe Glenoid shoulder components due to nonconforming packaging. The affected units were packaged in vacuum bags lacking the required oxygen barrier layer.
FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Becton Dickinson recalls BD Phoenix NMIC-306 microbiology diagnostic panels due to confirmed drug cross-contamination that may lead to incorrect bacterial identification and delayed treatment.
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
The Coca-Cola Company is recalling specific lots of Powerade Mountain Berry Blast distributed in South Carolina and Florida due to the potential presence of a stainless-steel ring in some bottles.
Coca-Cola is recalling certain Powerade Zero Mixed Berry 20 oz bottles due to potential presence of a stainless steel ring. Affected bottles were distributed to consignees in South Carolina and Florida.
AJI MORI Chillimami Sauce (250ml bottles) is being recalled due to potential contamination with Clostridium botulinum. The recall affects 78 bottles distributed to consumers in multiple states.
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
Stryker recalled specific lots of Infinity Resection Adjustment Blocks due to a missing internal screw that locks the medial/lateral adjustment mechanism. The defect affects 47 units used in ankle arthroplasty procedures.
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.