[ 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 |
|---|---|---|---|---|
| 2026-06-17 | Class II | Siemens Healthcare Diagnostics, Inc.Z-2398-2026 | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. | — |
| 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 | 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-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 | 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 II | CareFusion 303, Inc.Z-2300-2026 | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | — |
| 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 | 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 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 | B Braun Medical IncZ-2265-2026 | 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 | 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 | Advanced Bionics, LLCZ-2283-2026 | Due to incorrect shelf-life expiration date. | Validation & Qualification |
| 2026-06-10 | Class II | CareFusion 303, Inc.Z-2298-2026 | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | — |
| 2026-06-10 | Class I | Becton Dickinson & CompanyZ-2253-2026 | 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 | Kico Knee Innovation CompanyZ-2293-2026 | The Impactor 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 | 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 | 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-2264-2026 | 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 | 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 | Covidien LLCZ-2261-2026 | Due to customer complaint regarding incorrect display box labeling. | Documentation & Change Control |
| 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 | GE Medical Systems China Co., Ltd.Z-2306-2026 | Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making. | Data Integrity |
| 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 II | DeRoyal Industries IncZ-2305-2026 | Sterile wound dressing, lacks sterility assurance | Environmental Monitoring |
| 2026-06-10 | Class II | B Braun Medical IncZ-2269-2026 | 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. | — |
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.