Medline Namic Guidewires Class II Recall

FDA

Changeflow GovPing Government General Medline Namic Guidewires Class II Recall

Urgent Enforcement Amended Final

Medline Namic Guidewires Class II Recall

FDA Device Recalls (Class II)

Filed April 17th, 2026

Detected April 21st, 2026

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Summary

FDA classified a Class II recall for Medline Namic Guidewires, including 30 model numbers of guidewires used in catheter procedures. The recall was initiated by the firm on February 25, 2026, and affects numerous lot numbers distributed across multiple product codes. Healthcare facilities with these devices in stock should identify and quarantine affected lots using the provided UDI-DI and lot number information.

Published by FDA on accessdata.fda.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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What changed

FDA classified a Class II device recall for Medline Namic Guidewires spanning 30 distinct model numbers across multiple guidewire configurations. The affected products include both standard guidewires and hydrophilic-coated variants in multiple lengths and tip configurations. Healthcare providers and facilities that have distributed or use these guidewires should immediately check inventory against the specified lot numbers and UDI-DI codes to identify affected units. Quarantined products should be held pending further instructions from Medline or FDA.

Facilities should review their purchasing and inventory records to identify any patients who may have received affected devices, as guidewire failures during procedures could result in patient injury requiring additional intervention. Distributors and group purchasing organizations that supplied these products should coordinate with their customers on the recall notification.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Class 2 Device Recall Namic Guidewires

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| | Class 2 Device Recall Namic Guidewires | |

Date Initiated by Firm	February 25, 2026
Date Posted	April 17, 2026
Recall Status	Open , Classified
Recall Number	Z-1829-2026
Recall Event ID	98599
Product Classification	Wire, guide, catheter - Product Code DQX
Product	Medline Namic Guidewires:

1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L;
2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105;
3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107;
4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115;
5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108;
6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104;
7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113;
8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103;
9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L;
10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L;
11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112;
12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109;
13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102;
14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106;
15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110;
16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121;
17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122;
18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118;
19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127;
20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130;
21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123;
22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124;
23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116;
24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126;
25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111;
26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100;
27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101;
28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125;
29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119;
30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120 |
| Code Information | 1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001;
2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001;
3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562;
4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956;
5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001;
6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925;
7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410;
8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001;
9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440;
10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254;
11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057;
12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513;
13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513;
14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853;
15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001;
16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300;
17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361;
18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513;
19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001;
20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409;
21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536;
22) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBV499;
23) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 34124110001;
24) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 23BBE325;
25) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBF377;
26) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBP677;
27) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24EBT215;
28) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24FBB651;
29) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24GBN276;
30) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 25JDB022;
31) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 34124110001;
32) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23BBI328;
33) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23EBX142;
34) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24CBI166;
35) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24EBB935;
36) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 34125010001;
37) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24CBP092;
38) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24GBQ708;
39) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24LBN511;
40) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 25IDB409;
41) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125030001;
42) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125040001;
43) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25HDB501;
44) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA596;
45) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA852;
46) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 34125030001;
47) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25IDA121;
48) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA209;
49) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA844;
50) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDB021;
51) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23BBC807;
52) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBF993;
53) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBX235;
54) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23BBI326;
55) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBG136;
56) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBW407;
57) DYNJHWIRE102, UDI-DI: 10195327301606(each), 40195327301607(case), Lot Number: 23EBB276;
58) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBB277;
59) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBW406;
60) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBB278;
61) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBW408;
62) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23EBB283;
63) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23HBC832;
64) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23JBI897;
65) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23EBB284;
66) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23GBO917;
67) DYNJHWIRE118, UDI-DI: 10195327308308(each), 40195327308309(case), Lot Number: 23EBB286;
68) DYNJHWIRE127, UDI-DI: 10195327308704(each), 40195327308705(case), Lot Number: 23EBB289;
69) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBB291;
70) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBW417;
71) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB293;
72) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB296;
73) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB312;
74) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23HBG331;
75) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBF995;
76) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBW413;
77) DYNJHWIRE116, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23EBT183;
78) DYNJHWIRE126, UDI-DI: 10195327308698(each), 40195327308699(case), Lot Number: 23EBW418;
79) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24ABA433;
80) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24CBT125;
81) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24EBC837;
82) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24FBK897;
83) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24GBL572;
84) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24LBN512;
85) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 24DBT415;
86) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25CBT320;
87) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25IDA783;
88) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 24GBX216;
89) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 25JDA210;
90) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBW414;
91) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBB287;
92) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBB282;
93) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBW411;
94) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23GBG005;
95) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBW412;
96) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBF994 |
| FEI Number | 1417592 |
| Recalling Firm/
Manufacturer | Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley Barclay
866-359-1704 |
| Manufacturer Reason
for Recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| FDA Determined
Cause | No Marketing Application |
| Action | An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers.

REQUIRED ACTION:
1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product.
2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to
Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1
Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit.
4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers.
Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com.

*** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers.

This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification.

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

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April 21, 2026

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FDA

Filed

April 17th, 2026

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Executive

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Final

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Substantive

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Applies to

Medical device makers Healthcare providers

Industry sector

3345 Medical Device Manufacturing

Activity scope

Product recall response Medical device distribution

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United States US

Taxonomy

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Medical Devices

Operational domain

Clinical Operations

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GxP

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Healthcare Product Safety

Medline Namic Guidewires Class II Recall

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Class 2 Device Recall Namic Guidewires

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3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

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