[ 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 | 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 | 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 | 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 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 | 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 | 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 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2290-2026 | 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 | Covidien, LPZ-2281-2026 | The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. | Environmental Monitoring |
| 2026-06-10 | Class II | DeRoyal Industries IncZ-2305-2026 | Sterile wound dressing, lacks sterility assurance | Environmental Monitoring |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2286-2026 | 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 | Covidien LLCZ-2271-2026 | Temperature probe devices lack FDA clearance. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2289-2026 | 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-2207-2026 | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. | — |
| 2026-06-03 | Class I | Medline Industries, LPZ-2232-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class II | GE Medical Systems Information Technologies IncZ-2247-2026 | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | — |
| 2026-06-03 | Class II | Medtronic NeuromodulationZ-2240-2026 | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Documentation & Change Control |
| 2026-06-03 | Class II | GE Medical Systems Information Technologies IncZ-2244-2026 | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | — |
| 2026-06-03 | Class I | Abiomed, Inc.Z-2238-2026 | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console. | — |
| 2026-06-03 | Class II | O&M HALYARD INCZ-2230-2026 | Nitrile Exam Glove failed to meet specifications chemical permeation performance. | — |
| 2026-06-03 | Class I | Medline Industries, LPZ-2233-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class I | Abiomed, Inc.Z-2211-2026 | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures. | Risk Management & CAPA |
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.