FDA Medical Device Recall Enforcement Quarterly Archive

What this product does

Immutable normalized edition of current-quarter FDA medical-device recall enforcement reports with classification, firm, product, reason, distribution, and first-party evidence fields.

Who it is for

Not published yet.

Problems solved

Not published yet.

Update cadence

4 hours ago

Pricing and access note

Not published yet. Pricing will appear on the verified external marketplace listing.

Source and provenance note

Foundry product package: ProductStudio public-safe metadata

Limitations

Review the sample, schema, source notes, marketplace availability, and cadence before depending on this product in production.

Delivery options

Not published yet. A link appears only after a verified external marketplace destination exists.

Sample and schema preview

• recall_number (string)
• report_date (string)
• recall_initiation_date (string)
• classification (string)
• status (string)
• recalling_firm (string)
• product_description (string)
• reason_for_recall (string)
• product_quantity (string)
• distribution_pattern (string)

{
  "rows": [
    {
      "state": "IL",
      "status": "Ongoing",
      "country": "United States",
      "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number.exact%3A%22Z-2537-2026%22&limit=1",
      "report_date": 20260708,
      "recall_number": "Z-2537-2026",
      "classification": "Class II",
      "recalling_firm": "Medline Industries, LP",
      "product_quantity": "333 kits",
      "reason_for_recall": "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.",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "product_description": "Medline Convenience Kits:  1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF;   2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE;   3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_initiation_date": 20260521
    },
    {
      "state": "IL",
      "status": "Ongoing",
      "country": "Uni

Related products and use cases

Related products and use-case links are not published yet.