Medline Industries, Inc. DYNJ901203DRecalls & reported problems
Medline Industries, Inc. · OPEN HEART A&B · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 4, 2026Open, Classified
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Z-2487-2026 · Root cause: Nonconforming Material/Component · FDA record ↗
- Mar 19, 2026Open, Classified
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Z-2016-2026 · Root cause: Under Investigation by firm · FDA record ↗
- Nov 21, 2024Open, Classified
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Z-0778-2025 · Root cause: Nonconforming Material/Component · FDA record ↗
Other Cardiovascular procedure kit devices
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- Medline Industries, Inc. CDS983513FMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. DYNJ51038RMedline Industries, Inc. · Cardiovascular procedure kit4 recalls2 reports
- Medline Industries, Inc. CDS983773JMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ42921GMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ50478FMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.