FDAClass II · Medical device · Recall Z-3111-2026 · Recalled September 16, 2026

Getinge PVC Thoracic Catheter recall — Atrium Medical Corporation

Agency report date: September 16, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Getinge PVC Thoracic Catheter
Company / brand: Atrium Medical
Lot / serial / date codes: 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
Distribution: US Nationwide distribution.

Agency product description and boundaries

Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Getinge PVC Thoracic Catheter recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3111-2026
Brand: All Atrium Medical recalls
Classification: Class II
Units affected: 3,618
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Getinge PVC Thoracic Catheter recall status

Companies & origin

Recalling firm location: Merrimack, NH, United States
Firm address: 40 Continental Blvd, 03054-4332

Identifying details (verbatim from the notice)

Product codes / lots: 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
Distribution: US Nationwide distribution.
FDA event ID: 99680
Recall initiated: August 7, 2026
FDA classified: September 4, 2026
FDA report date: September 16, 2026

Other medical device recalls from around the same time

DuoGlide Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.FDA · September 23, 2026
Power-Trialysis Short-Term Straight Dialysis Catheter recall — Bard Access Systems, Inc.FDA · September 23, 2026
Kit recall — Medical Action Industries, Inc. 306FDA · September 16, 2026
Kit recall — Medical Action Industries, Inc. 306FDA · September 16, 2026
Bravo CF capsule delivery device recall — Given Imaging Ltd.FDA · September 16, 2026

Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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