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.
Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
GE F2-01 Frame physiological patient monitors may experience data communication interruptions with CARESCAPE ONE and CARESCAPE Canvas 1000 monitors if not powered down within 120 days.
Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.
The FDA is recalling rocuronium 50 mg/5 mL syringes from Central Admixture Pharmacy Services Inc due to lack of assurance of sterility. Approximately 1,389 syringes with affected lot numbers have been distributed nationwide.
Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.
Central Admixture Pharmacy Services recalled 174 fentanyl syringes nationwide due to lack of sterility assurance. The affected injectable medication presents a contamination risk.
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.
Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.
Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.
Olympus Veran percutaneous navigation systems are recalled due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence, affecting approximately 9,961 units distributed worldwide.
AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.
Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.
Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.
Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling 1,590 syringes of ePHEDrine due to lack of assurance of sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.
The Puritan Bennett Cuff Pressure Manager's internal power inlet can become dislodged, preventing the device from charging. This may delay patient treatment.
Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.
Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the labeled specifications.
Fentanyl 1,250 mcg/25 mL syringes from Central Admixture Pharmacy Services Inc are being recalled nationwide due to lack of assurance of sterility. The manufacturer could not confirm that affected lots meet required sterility standards.
Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters because they were manufactured with an incorrect tip curve shape that differs from the labeled specification.