Smiths Medical ProPort Plastic Access System Recall: Port Housing Separation Risk
Smiths Medical recalls ProPort Plastic Venous Access Systems due to potential port housing separation from manufacturing defects. Affected units include specific lot numbers and UDI/DI codes.
Use caution until it’s fixed
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Contact the company
What happened, in plain English
Smiths Medical is recalling certain ProPort Plastic Venous Access Systems because a manufacturing defect may cause the port housing and reservoir to separate. This could lead to complications if the device becomes dislodged during medical use. Read more at govinfonow.com/recall/52864-smiths-medical-proport-plastic-access-system-recall-port-housing-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/52864-smiths-medical-proport-plastic-access-system-recall-port-housing-separation · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1286-2025
Cite this page
“Smiths Medical ProPort Plastic Access System Recall: Port Housing Separation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52864-smiths-medical-proport-plastic-access-system-recall-port-housing-separation. Based on FDA recall #Z-1286-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1286-2025%22&limit=1).
Why it’s dangerous
The plastic port housing and reservoir can separate due to a manufacturing defect. This separation could cause the device to become dislodged, potentially leading to complications during medical procedures.
Who’s affected
Healthcare professionals using the ProPort systems for implanted venous access are most at risk. Patients with these devices may need to monitor for separation issues.
How to tell if you have this one
Check for the UDI/DI code 10610586012754 and lot numbers starting with 4196769 on the product packaging. The affected systems are labeled as 'Smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24'.
- Brand
Smiths Medical- Category
Medical device
All 12 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1277-2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24; UDI/DI 10610586012518, Lot Number 4235595 | 3 units |
| Z-1278-2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24; UDI/DI 10610586012532, Lot Numbers: 3968088, 4052396, 4063411, 4101698, 4122782, 4219344, 4232319, 4235596, 4242786, 4317072, 4325879, 4397749, 4420759, 4445594, 4449874. | 643 units |
| Z-1279-2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24; UDI/DI 10610586012549, Lot Numbers: 3928188, 3953708, 3957301, 3968097, 3977434, 3988450, 4006475, 4022600, 4027912, 4036893, 4073108, 4086999, 4103105, 4114110, 4122783, 4136362, 4139518, 4152689, 4153871, 4173433, 4189866, 4222392, 4227822, 4235597, 4276226, 4307472, 4317085, 4349806, 4378522, 4387732, 4395511, 4460618, 4434228, 4449233, 4449875, 6013082, 6014983, 4468606, 4426417, 6062037, 6071256. | 2311 units |
| Z-1280-2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24; UDI/DI 10610586012563, Lot Numbers: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416. | 9506 units |
| Z-1281-2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24; UDI/DI 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258. | 3263 units |
| Z-1282-2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24; UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890. | 1695 units |
| Z-1283-2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24; UDI/DI 10610586012716, Lot Numbers: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026. | 1961 units |
| Z-1284-2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24; UDI/DI 10610586012723, Lot Numbers: 4235509 | 1 unit |
| Z-1285-2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24; UDI/DI 10610586012747, Lot Numbers: 4317077 | 12 units |
| Z-1286-2025 | smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24; UDI/DI 10610586012754, Lot Numbers: 4196769 | 0 units |
| Z-1287-2025 | smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24; UDI/DI 10610586012778, Lot Numbers: 3916028, 3969277, 4006477, 4022602, 4036895, 4057818, 4060894, 4096338, 4108453, 4114117, 4146468, 4153874, 4163556, 4196775, 4221727, 4235565, 4235567, 4235601, 4248694, 4256927, 4256928, 4256964, 4276228, 4294894, 4294895, 4364693, 4366695, 4366696, 4378523, 4382349, 4392370, 4395513, 4405010, 4420761, 4426418, 4434230, 4453606, 4468579, 4468580, 6005957, 6005958, 6026650, 6026651, 6037122, 6037124, 6051325. | 8515 units |
| Z-1288-2025 | smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24; UDI/DI 10610586012839, Lot Numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259. | 2236 units |
What to do — step by step
Check Product Details
Look for the UDI/DI code 10610586012754 and lot numbers starting with 4196769 on the product packaging.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1286-2025 (February 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1286-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.