MAUDEScope feed

Every path below is a static file. No account, no key, no quota, and the same bytes for every caller — which is also what makes the hashes in the manifest worth anything.

Source: openFDA device/event, device/recall and device/classification, retrieved 2026-09-08. Snapshot 2026-09-15. Method maude-method-0.1 (draft). n=64,841 reports across 5 product codes.

Linked is the share of reports that the clustering assigned to a cluster with another report in it — one event reported more than once. It is a method output with no measured error: precision and recall need the hand-labelled set described on the method page, and it is not labelled yet. Read it as "this is what the method found", not "this is how much of MAUDE is duplicated".

• EOB Survives deduplication 2026-09-30

  EOB 2026Q3: reports above threshold (part-quarter)

  2026Q3: 798 reports received under product code EOB, above the threshold of 646.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 703 estimated distinct events. This quarter is INCOMPLETE: openFDA's file was cut inside it, so the count covers part of a quarter. It cleared the threshold on partial data, and it cannot be compared like-for-like with the complete quarters before it. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause.

• EOB Survives deduplication 2026-06-30

  EOB 2026Q2: reports above threshold

  2026Q2: 960 reports received under product code EOB, above the threshold of 522.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 894 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause.

• DQO Survives deduplication 2026-06-30

  DQO 2026Q2: reports above threshold

  2026Q2: 234 reports received under product code DQO, above the threshold of 202.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 170 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1934-2026, Z-1935-2026, Z-1936-2026, Z-1823-2026, Z-1778-2026, Z-1856-2026, Z-1857-2026, Z-1858-2026, Z-1859-2026, Z-1860-2026, Z-1861-2026, Z-1862-2026, Z-1863-2026, Z-1864-2026, Z-1865-2026, Z-1866-2026, Z-1867-2026, Z-1868-2026, Z-1869-2026, Z-1870-2026, Z-1871-2026, Z-1872-2026, Z-1873-2026, Z-1874-2026, Z-1875-2026.

• DQO Recall 2026-04-02

  DQO: FDA device recall Z-1936-2026

  Recall Z-1936-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682

• DQO Recall 2026-04-02

  DQO: FDA device recall Z-1935-2026

  Recall Z-1935-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682

• DQO Recall 2026-04-02

  DQO: FDA device recall Z-1934-2026

  Recall Z-1934-2026 was initiated 2026-04-02 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98682

• EOB Survives deduplication 2026-03-31

  EOB 2026Q1: reports above threshold

  2026Q1: 461 reports received under product code EOB, above the threshold of 407.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 442 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause.

• DQO Survives deduplication 2026-03-31

  DQO 2026Q1: reports above threshold

  2026Q1: 211 reports received under product code DQO, above the threshold of 203.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 140 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1823-2026, Z-1778-2026, Z-1856-2026, Z-1857-2026, Z-1858-2026, Z-1859-2026, Z-1860-2026, Z-1861-2026, Z-1862-2026, Z-1863-2026, Z-1864-2026, Z-1865-2026, Z-1866-2026, Z-1867-2026, Z-1868-2026, Z-1869-2026, Z-1870-2026, Z-1871-2026, Z-1872-2026, Z-1873-2026, Z-1874-2026, Z-1875-2026.

• DQO Recall 2026-03-23

  DQO: FDA device recall Z-1823-2026

  Recall Z-1823-2026 was initiated 2026-03-23 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Device Design. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98619

• DQO Recall 2026-03-05

  DQO: FDA device recall Z-1778-2026

  Recall Z-1778-2026 was initiated 2026-03-05 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Incorrect or no expiration date. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98495

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1875-2026

  Recall Z-1875-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1874-2026

  Recall Z-1874-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1873-2026

  Recall Z-1873-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1872-2026

  Recall Z-1872-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1871-2026

  Recall Z-1871-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1870-2026

  Recall Z-1870-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1869-2026

  Recall Z-1869-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1868-2026

  Recall Z-1868-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1867-2026

  Recall Z-1867-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1866-2026

  Recall Z-1866-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1865-2026

  Recall Z-1865-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1864-2026

  Recall Z-1864-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1863-2026

  Recall Z-1863-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1862-2026

  Recall Z-1862-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1861-2026

  Recall Z-1861-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1860-2026

  Recall Z-1860-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1859-2026

  Recall Z-1859-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1858-2026

  Recall Z-1858-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1857-2026

  Recall Z-1857-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• DQO Recall 2026-03-03

  DQO: FDA device recall Z-1856-2026

  Recall Z-1856-2026 was initiated 2026-03-03 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Nonconforming Material/Component. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=98463

• EOB Survives deduplication 2025-12-31

  EOB 2025Q4: reports above threshold

  2025Q4: 481 reports received under product code EOB, above the threshold of 398.0 set by the preceding eight quarters. After deduplication the quarter still stands out: 440 estimated distinct events. No FDA device recall for this product code was initiated in the quarter or the two before it. The quarter is unannotated, which is not the same as having no cause.

• DQO Does not survive deduplication 2025-12-31

  DQO 2025Q4: reports above threshold — does not survive deduplication

  2025Q4: 203 reports received under product code DQO, above the threshold of 199.0 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (120 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1902-2025.

• DQO Recall 2025-05-15

  DQO: FDA device recall Z-1902-2025

  Recall Z-1902-2025 was initiated 2025-05-15 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Process change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=96848

• DQO Does not survive deduplication 2024-12-31

  DQO 2024Q4: reports above threshold — does not survive deduplication

  2024Q4: 147 reports received under product code DQO, above the threshold of 143.5 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (114 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-2453-2024, Z-2454-2024, Z-1904-2024.

• DQO Survives deduplication 2024-09-30

  DQO 2024Q3: reports above threshold

  2024Q3: 140 reports received under product code DQO, above the threshold of 125.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 119 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-2453-2024, Z-2454-2024, Z-1904-2024, Z-1638-2024, Z-1639-2024, Z-1640-2024, Z-1641-2024, Z-1642-2024, Z-1643-2024, Z-1644-2024, Z-1645-2024, Z-1646-2024, Z-1647-2024, Z-1648-2024, Z-1649-2024, Z-1650-2024, Z-1651-2024, Z-1652-2024, Z-1653-2024, Z-1654-2024, Z-1655-2024, Z-1656-2024, Z-1657-2024, Z-1658-2024, Z-1659-2024, Z-1660-2024, Z-1661-2024, Z-1662-2024, Z-1663-2024, Z-1664-2024, Z-1665-2024, Z-1666-2024, Z-1667-2024, Z-1668-2024, Z-1669-2024, Z-1670-2024, Z-1671-2024, Z-1672-2024, Z-1673-2024, Z-1674-2024, Z-1675-2024, Z-1676-2024, Z-1677-2024, Z-1678-2024, Z-1679-2024, Z-1680-2024, Z-1681-2024, Z-1682-2024, Z-1683-2024, Z-1684-2024, Z-1685-2024.

• LRC Does not survive deduplication 2024-06-30

  LRC 2024Q2: reports above threshold — does not survive deduplication

  2024Q2: 26 reports received under product code LRC, above the threshold of 10.0 set by the preceding eight quarters — but the quarter does NOT stand out after deduplication (10 estimated distinct events). On this method that is a reporting pattern rather than a change in the number of events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1474-2024, Z-0574-2024.

• DQO Recall 2024-06-18

  DQO: FDA device recall Z-2454-2024

  Recall Z-2454-2024 was initiated 2024-06-18 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Packaging change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94903

• DQO Recall 2024-06-18

  DQO: FDA device recall Z-2453-2024

  Recall Z-2453-2024 was initiated 2024-06-18 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Packaging change control. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94903

• DQO Recall 2024-04-23

  DQO: FDA device recall Z-1904-2024

  Recall Z-1904-2024 was initiated 2024-04-23 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Process design. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94437

• DQO Survives deduplication 2024-03-31

  DQO 2024Q1: reports above threshold

  2024Q1: 114 reports received under product code DQO, above the threshold of 113.5 set by the preceding eight quarters. After deduplication the quarter still stands out: 102 estimated distinct events. FDA device recall(s) initiated for this product code in the quarter or the two before it: Z-1638-2024, Z-1639-2024, Z-1640-2024, Z-1641-2024, Z-1642-2024, Z-1643-2024, Z-1644-2024, Z-1645-2024, Z-1646-2024, Z-1647-2024, Z-1648-2024, Z-1649-2024, Z-1650-2024, Z-1651-2024, Z-1652-2024, Z-1653-2024, Z-1654-2024, Z-1655-2024, Z-1656-2024, Z-1657-2024, Z-1658-2024, Z-1659-2024, Z-1660-2024, Z-1661-2024, Z-1662-2024, Z-1663-2024, Z-1664-2024, Z-1665-2024, Z-1666-2024, Z-1667-2024, Z-1668-2024, Z-1669-2024, Z-1670-2024, Z-1671-2024, Z-1672-2024, Z-1673-2024, Z-1674-2024, Z-1675-2024, Z-1676-2024, Z-1677-2024, Z-1678-2024, Z-1679-2024, Z-1680-2024, Z-1681-2024, Z-1682-2024, Z-1683-2024, Z-1684-2024, Z-1685-2024, Z-1084-2024, Z-0286-2024.

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1685-2024

  Recall Z-1685-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1684-2024

  Recall Z-1684-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1683-2024

  Recall Z-1683-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1682-2024

  Recall Z-1682-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1681-2024

  Recall Z-1681-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1680-2024

  Recall Z-1680-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1679-2024

  Recall Z-1679-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1678-2024

  Recall Z-1678-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1677-2024

  Recall Z-1677-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• DQO Recall 2024-03-21

  DQO: FDA device recall Z-1676-2024

  Recall Z-1676-2024 was initiated 2024-03-21 for product code DQO (Catheter, Intravascular, Diagnostic). Status: Open, Classified. Root cause as classified by FDA: Under Investigation by firm. FDA's own record, including the recall reason in FDA's words: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=94240

• no denominator MAUDE contains counts, not rates. No public dataset says how many of a device were sold, implanted or used, so nothing here is divided by anything and no rate is computed.
• not causation An MDR is a report, not a finding. FDA does not verify reports and a report does not establish that a device caused the event.
• dedup unvalidated The clustering has no published precision or recall. That needs the hand-labelled gold set (MAUDEScope spec 5.11), which is not labelled yet. Run gold_sample.py to emit the pairs. Until the labels come back, the duplicate rate is a method output with no measured error.
• draft thresholds The band boundaries in method.json are authored choices, not a published standard. Every band prints beside the raw value it came from.
• summary reporting unchecked Whether a product code was covered by FDA's Alternative Summary Reporting or Voluntary Malfunction Summary Reporting programs is not checked: neither list is in openFDA and neither source URL is verified for this build.
• no composite grade There is no single letter grade. Rolling ten dimensions into one requires weights that no published standard supplies, and the composite would be the most quotable number here and the least defensible.