[ 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.

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409 matching recalls
DateClassFirmReasonQuality domain
2026-06-10Class IB Braun Medical IncZ-2276-2026These 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
2026-06-10Class IBecton Dickinson & CompanyZ-2254-2026This 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
2026-06-10Class IIStryker CorporationZ-2282-2026It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.Risk Management & CAPA
2026-06-10Class IB Braun Medical IncZ-2277-2026These 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
2026-06-10Class IBecton Dickinson & CompanyZ-2250-2026This 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
2026-06-10Class IBecton Dickinson & CompanyZ-2257-2026This 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
2026-06-10Class IBecton Dickinson & CompanyZ-2252-2026This 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
2026-06-10Class IBecton Dickinson & CompanyZ-2251-2026This 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
2026-06-10Class IBecton Dickinson & CompanyZ-2253-2026This 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
2026-06-10Class IBecton Dickinson & CompanyZ-2255-2026This 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
2026-06-03Class IAbiomed, Inc.Z-2211-2026A 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
2026-05-27Class IIZydus Pharmaceuticals (USA) IncD-0544-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-27Class IIBecton, Dickinson and CompanyZ-2204-2026Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
2026-05-27Class IIBecton, Dickinson and CompanyZ-2202-2026Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
2026-05-27Class IIZydus Pharmaceuticals (USA) IncD-0545-2026CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRisk Management & CAPA
2026-05-27Class IIBecton, Dickinson and CompanyZ-2203-2026Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2079-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2078-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2070-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2074-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IISpacelabs Healthcare, Inc.Z-2052-2026Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2073-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2071-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2069-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIKatalyst Surgical, LLCZ-2077-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
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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.