Regulatory Record: Erbe Medical, LLC

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Erbe Medical, LLC has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-05-13, Argus HQ recorded a FDA recall for Erbe Medical, LLC, rated "high" severity in Argus HQ's classification: Erbe Medical, LLC — Class II recall: ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Source… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Erbe Medical, LLC, rated "high" severity in Argus HQ's classification: Erbe Medical, LLC — Class II recall: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Erbe Medical, LLC, rated "high" severity in Argus HQ's classification: Erbe Medical, LLC — Class II recall: ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Erbe Medical, LLC has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

How many FDA actions has Erbe Medical, LLC had?

Argus HQ has recorded 3 FDA events for Erbe Medical, LLC: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Erbe Medical, LLC?

The most recent FDA event Argus HQ has on file for Erbe Medical, LLC is dated 2026-05-13, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Erbe Medical, LLC automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Erbe Medical, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Erbe Medical, LLC?

3 total: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Erbe Medical, LLC — Class II recall: ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO… →
• Erbe Medical, LLC — Class II recall: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 →
• Erbe Medical, LLC — Class II recall: ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Source… →

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