[ 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.
1,158 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2564-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medline Industries, LPZ-2582-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Philips North America LlcZ-2523-2026 | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Documentation & Change Control |
| 2026-07-01 | Class II | GE Medical Systems SCSZ-2553-2026 | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment. | Documentation & Change Control |
| 2026-07-01 | Class II | Medline Industries, LPZ-2585-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Medline Industries, LPZ-2588-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2557-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medline Industries, LPZ-2592-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2570-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medtronic Perfusion SystemsZ-2575-2026 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Documentation & Change Control |
| 2026-07-01 | Class I | Medline Industries, LPZ-2454-2026 | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. | — |
| 2026-07-01 | Class I | Medline Industries, LPZ-2452-2026 | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. | — |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2578-2026 | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | Documentation & Change Control |
| 2026-07-01 | Class II | Medline Industries, LPZ-2581-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2561-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medline Industries, LPZ-2594-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2531-2026 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Risk Management & CAPA |
| 2026-07-01 | Class II | Stryker NeurovascularZ-2552-2026 | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. | — |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2572-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Intuitive Surgical, Inc.Z-2521-2026 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding. | — |
| 2026-07-01 | Class I | Abiomed, Inc.Z-2600-2026 | Potential for thrombus formation during prolonged use of the introducer. | — |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2565-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Medtronic Perfusion SystemsZ-2576-2026 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Documentation & Change Control |
| 2026-07-01 | Class I | Medline Industries, LPZ-2455-2026 | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. | — |
| 2026-07-01 | Class II | Medline Industries, LPZ-2589-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
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.