[ 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 |
|---|---|---|---|---|
| 2026-06-10 | Class II | B Braun Medical IncZ-2267-2026 | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | — |
| 2026-06-10 | Class I | KAYSERBETTEN GMBH & CO. KGZ-2212-2026 | If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children). | — |
| 2026-06-10 | Class II | B Braun Medical IncZ-2263-2026 | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | — |
| 2026-06-10 | Class II | Daavlin Distributing CompanyZ-2295-2026 | Some of the Calibration/Output Certificates had the outputs reversed. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2288-2026 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | — |
| 2026-06-10 | Class II | Kico Knee Innovation CompanyZ-2292-2026 | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. | — |
| 2026-06-10 | Class II | Oculus Technologies of Mexico, S.A. de C.V.Z-2275-2026 | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use. | — |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2250-2026 | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Risk Management & CAPA |
| 2026-06-10 | Class I | Draeger, Inc.Z-2208-2026 | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2284-2026 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2285-2026 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | — |
| 2026-06-10 | Class II | B Braun Medical IncZ-2266-2026 | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. | — |
| 2026-06-10 | Class II | Covidien LLCZ-2261-2026 | Due to customer complaint regarding incorrect display box labeling. | Documentation & Change Control |
| 2026-06-10 | Class I | B Braun Medical IncZ-2277-2026 | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | Risk Management & CAPA |
| 2026-06-10 | Class II | CareFusion 303, Inc.Z-2301-2026 | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | — |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2257-2026 | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Risk Management & CAPA |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2254-2026 | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Risk Management & CAPA |
| 2026-06-10 | Class II | Bayer Medical Care, Inc.Z-2296-2026 | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption. | — |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2251-2026 | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Risk Management & CAPA |
| 2026-06-10 | Class I | B Braun Medical IncZ-2276-2026 | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection. | Risk Management & CAPA |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2248-2026 | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing. | Risk Management & CAPA |
| 2026-06-10 | Class II | Siemens Medical Solutions USA, IncZ-2205-2026 | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. | — |
| 2026-06-10 | Class II | Covidien LLCZ-2273-2026 | Temperature probe devices lack FDA clearance. | — |
| 2026-06-10 | Class II | CareFusion 303, Inc.Z-2297-2026 | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | — |
| 2026-06-10 | Class I | Fresenius Kabi USA, LLCZ-2223-2026 | Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power. | Data Integrity |
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.