OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm, 010-1
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
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FDA
Z-2213-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 23, 2026
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Details |
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 7
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
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FDA
Z-2225-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 28, 2026
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Details |
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FDA
Z-2221-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
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Details |
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FDA
Z-2217-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
|
Details |
Swan-Ganz Pacing Catheter, Models: D200F7;
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
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FDA
Z-2204-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 8, 2026
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Details |
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FDA
Z-2214-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
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Details |
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FDA
Z-2216-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
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Details |
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|
FDA
Z-2219-2026
|
Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
|
Details |
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|
FDA
Z-2218-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 21, 2026
|
Details |
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
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FDA
Z-2227-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 28, 2026
|
Details |
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FDA
Z-2203-2026
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Medical Device |
High |
May 27, 2026
Recall: Apr 8, 2026
|
Details |
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|
FDA
Z-2182-2026
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Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
|
Details |
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ5
Medline has identified the presence of particulate within the fluid path of the Manifolds.
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FDA
Z-2147-2026
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Medical Device |
High |
May 20, 2026
Recall: Mar 24, 2026
|
Details |
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FDA
Z-2175-2026
|
Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
|
Details |
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FDA
Z-2178-2026
|
Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
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Details |
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FDA
Z-2142-2026
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Medical Device |
High |
May 20, 2026
Recall: Mar 24, 2026
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Details |
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FDA
Z-2140-2026
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Medical Device |
High |
May 20, 2026
Recall: Mar 24, 2026
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Details |
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FDA
Z-2193-2026
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Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
|
Details |
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FDA
Z-2150-2026
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Medical Device |
High |
May 20, 2026
Recall: Mar 26, 2026
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Details |
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FDA
Z-2197-2026
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Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
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Details |
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FDA
Z-2196-2026
|
Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
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Details |
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FDA
Z-2184-2026
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Medical Device |
High |
May 20, 2026
Recall: Apr 10, 2026
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Details |
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FDA
Z-2137-2026
|
Medical Device |
High |
May 20, 2026
Recall: Mar 19, 2026
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Details |
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|
FDA
Z-2138-2026
|
Medical Device |
High |
May 20, 2026
Recall: Mar 24, 2026
|
Details |
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|
FDA
Z-2161-2026
|
Medical Device |
High |
May 20, 2026
Recall: Apr 13, 2026
|
Details |