[ 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 |
|---|---|---|---|---|
| 2026-07-15 | Class II | Elekta, Inc.Z-2712-2026 | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | — |
| 2026-07-15 | Class II | Olympus Corporation of the AmericasZ-2676-2026 | Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. | — |
| 2026-07-15 | Class II | Siemens Healthcare Diagnostics, Inc.Z-2703-2026 | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. | Validation & Qualification |
| 2026-07-15 | Class II | WALLAC OYZ-2713-2026 | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. | Validation & Qualification |
| 2026-07-15 | Class II | ConvaTec, IncZ-2677-2026 | Surgical dressing manufactured out of specification (greater thickness). | Validation & Qualification |
| 2026-07-15 | Class II | Klowen BracesZ-2699-2026 | A product error defect may cause incorrect bracket placement. | Documentation & Change Control |
| 2026-07-15 | Class II | Elekta, Inc.Z-2710-2026 | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. | — |
| 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 |
| 2026-07-15 | Class II | CMR SURGICAL LIMITEDZ-2717-2026 | Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. | Data Integrity |
| 2026-07-15 | Class II | Integra LifeSciences Corp. (NeuroSciences)Z-2714-2026 | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. | Environmental Monitoring |
| 2026-07-15 | Class II | Fresenius Medical Care Holdings, Inc.Z-2702-2026 | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. | — |
| 2026-07-15 | Class II | Boston Scientific Neuromodulation CorporationZ-2694-2026 | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection. | Environmental Monitoring |
| 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 | 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 | Encore Medical, LPZ-2700-2026 | Due to packaging discrepancy with incorrect product size mixed up. | Documentation & Change Control |
| 2026-07-15 | Class II | Encore Medical, LPZ-2701-2026 | Due to packaging discrepancy with incorrect product size mixed up. | Documentation & Change Control |
| 2026-07-15 | Class II | Biomerieux IncZ-2715-2026 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | — |
| 2026-07-15 | Class II | Medtronic MiniMed, Inc.Z-2698-2026 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA). | Data Integrity |
| 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 |
| 2026-07-08 | Class II | Masimo CorporationZ-2670-2026 | Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness. | Documentation & Change Control |
| 2026-07-08 | Class II | Medline Industries, LPZ-2542-2026 | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. | Risk Management & CAPA |
| 2026-07-08 | Class II | Bard Access Systems, Inc.Z-2661-2026 | 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 | RAYSEARCH LABORATORIES ABZ-2646-2026 | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. | — |
| 2026-07-08 | Class II | Remel, IncZ-2623-2026 | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | — |
| 2026-07-08 | Class II | Boston Scientific CorporationZ-2629-2026 | Potential sterile breach of the pouches in which devices are packaged. | Environmental Monitoring |
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.