[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
409 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-07-22 | Class I | Abiomed, Inc.Z-2685-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2684-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Oscor Inc.Z-2680-2026 | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2689-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2682-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2691-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2688-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2683-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2690-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Oscor Inc.Z-2678-2026 | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Risk Management & CAPA |
| 2026-07-22 | Class I | Oscor Inc.Z-2679-2026 | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2687-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2686-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2681-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2692-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-22 | Class I | Abiomed, Inc.Z-2693-2026 | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Risk Management & CAPA |
| 2026-07-15 | Class II | Medline Industries, LPZ-2695-2026 | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Risk Management & CAPA |
| 2026-07-15 | Class II | Think Surgical, Inc.Z-2716-2026 | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. | Risk Management & CAPA |
| 2026-07-15 | Class II | Medline Industries, LPZ-2697-2026 | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Risk Management & CAPA |
| 2026-07-15 | Class II | Shimoga ChemicalsD-0691-2026 | cGMP deviations | Risk Management & CAPA |
| 2026-07-15 | Class II | Medline Industries, LPZ-2696-2026 | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2657-2026 | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | Risk Management & CAPA |
| 2026-07-08 | Class II | Cipla USA, Inc.D-0675-2026 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Risk Management & CAPA |
| 2026-07-08 | Class II | Cipla USA, Inc.D-0676-2026 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Risk Management & CAPA |
| 2026-07-08 | Class II | Cipla USA, Inc.D-0661-2026 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Risk Management & CAPA |
Page 1 of 17
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.