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.
Smiths Medical ASD Inc. is recalling Pneupac paraPAC plus 300 ventilator kits because the tidal volume knob may move from its original setting.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
Medline is recalling multiple convenience kits used in medical procedures due to plastic syringe defects including leaks and breakage. No injuries have been reported, but the defects may pose a risk to patient health.
Orwaiian LLC is recalling Birthday Cake Mochi Crunch due to missing allergen declarations on the label. The product contains milk and coconut but these are not listed in the Contains statement.
Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.
Pacific Lasertech is recalling the N-LHP-928 HeNe Laser System (35 mW) because the key-actuated safety control can be removed while the laser is operating, defeating the required master control mechanism.
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects kits with Pack Number DYNDH1453 distributed worldwide.
Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and may pose a risk to patient health.
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
Medline Industries is recalling various arthroscopy and arthrogram convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in US, Canada, and Panama.
Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.
Medline recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.
Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.