Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGR...
FDA Device Recall #Z-2159-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2159-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 55014 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D; e) VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG; f) ANGIO PACK-LF, Model Number DYNJ0373279M; g) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I; h) IPMC ANGIOGRAPHY PACK-LF, Model Number DYNJ0806254D; i) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485T; j) ANGIO DRAPE PACK, Model Number DYNJ17624B; k) DEPAUL ANGIO PACK, Model Number DYNJ19939M; l) EP ANGIOGRAPHY PACK, Model Number DYNJ24225K; m) ANGIOGRAPHY DRAPE PACK-LF, Model Number DYNJ28067G; n) DASHTI-YAO NEURO ANGIO-LF, Model Number DYNJ33457C; o) ANGIOGRAM TRAY, Model Number DYNJ33638K; p) ANGIO PACK, Model Number DYNJ34361; q) ANGIO/PICC PACK, Model Number DYNJ36049; r) IR MINOR ANGIO PACK, Model Number DYNJ37665B; s) ANGIO LEFT HEART PACK, Model Number DYNJ40632C; t) MV-IR ANGIO DRAPE PACK-LF, Model Number DYNJ41553D; u) CUSTOM ANGIO TRAY, Model Number DYNJ41649F; v) FS ANGIO, Model Number DYNJ42499C; w) ANGIO PACK, Model Number DYNJ42903B; x) ANGIO PACK, Model Number DYNJ43661B; y) ANGIOGRAPHY PACK, Model Number DYNJ44293D; z) ANGIO DRAPE PACK, Model Number DYNJ44320F; aa) ANGIOGRAM PACK, Model Number DYNJ45007; bb) ANGIO BASIN SET, Model Number DYNJ46043F; cc) ANGIO TRAY, Model Number DYNJ46153B; dd) ANGIOGRAM PACK, Model Number DYNJ47004C; ee) ANGIO PACK, Model Number DYNJ47226A; ff) ANGIOGRAPHY PACK, Model Number DYNJ47906; gg) ANGIO DRAPE SPEC PROC PACK-LF, Model Number DYNJ47951A; hh) MH HOOD CARDIAC ANGIO, Model Number DYNJ49884F; ii) ANGIO PACK, Model Number DYNJ50624A; jj) ANGIO PACK, Model Number DYNJ51239A; kk) ANGIO TRAY, Model Number DYNJ52121; ll) ANGIO PACK-LF, Model Number DYNJ52898C; mm) ANGIOGRAPHY PACK, Model Number DYNJ55252B; nn) ANGIOGRAPHY PACK, Model Number DYNJ57498; oo) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645B; pp) GENERAL ANGIO PACK, Model Number DYNJ57760B; qq) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792A; rr) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792B; ss) ANGIO PACK, Model Number DYNJ58126A; tt) HH ANGIO PACK, Model Number DYNJ59465B; uu) OR ANGIO PACK, Model Number DYNJ60319A; vv) ANGIO PACK 2-A, Model Number DYNJ60507A; ww) FEMORAL ANGIOGRAPY SET UP, Model Number DYNJ61015B; xx) ANGIO PACK, Model Number DYNJ62299; yy) CLOVIS CATH LAB PACK, Model Number DYNJ62379; zz) ANGIO PACK, Model Number DYNJ62544; aaa) ANGIO TRAY W/CHLORAPREP, Model Number DYNJ62742; bbb) OR ANGIO PAC , Model Number DYNJ63976A; ccc) SUNSHINE PAC , Model Number DYNJ64830; ddd) ANGIO PAC , Model Number DYNJ65043A; eee) CATH LAB PAC , Model Number DYNJ65185; fff) ANGIOGRAPHY PACK, Model Number DYNJ65190C; ggg) PACK,BASIC ANGIO, Model Number DYNJ65482A; hhh) ANGIO PACK, Model Number DYNJ66398B; iii) ANGIOGRAPHY PACK, Model Number DYNJ66476; jjj) SURGERY ANGIO PACK-LF, Model Number DYNJ66500; kkk) OR ANGIOGRAPHY PACK, Model Number DYNJ67245; lll) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065A; mmm) ANGIO TRAY, Model Number DYNJ68758; nnn) ANGIO, Model Number DYNJ902507B; ooo) ANGIOGRAPHY PACK, Model Number DYNJC2371G; ppp) ANGIOGRAPHY DRAPE PACK, Model Number DYNJT2344B; qqq) PEDI ANGIO PACK-LF, Model Number PHS41743D
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Information
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number 00-401318M, UDI/DI (EA)10193489348750, UDI/DI (CS)40193489348751 b) Model Number CDS984944C, UDI/DI (EA)10889942172955, UDI/DI (CS)40889942172956 c) Model Number DYNJ0149444M, UDI/DI (EA)10193489432824, UDI/DI (CS)40193489432825 d) Model Number DYNJ0160556D, UDI/DI (EA)10193489207552, UDI/DI (CS)40193489207553 e) Model Number DYNJ0201109AG, UDI/DI (EA)10193489497267, UDI/DI (CS)40193489497268 f) Model Number DYNJ0373279M, UDI/DI (EA)10193489519020, UDI/DI (CS)40193489519021 g) Model Number DYNJ0429121I, UDI/DI (EA)10193489897494, UDI/DI (CS)40193489897495 h) Model Number DYNJ0806254D, UDI/DI (EA)10889942471164, UDI/DI (CS)40889942471165 i) Model Number DYNJ0854485T, UDI/DI (EA)10193489864199, UDI/DI (CS)40193489864190 j) Model Number DYNJ17624B, UDI/DI (EA)10193489867299, UDI/DI (CS)40193489867290 k) Model Number DYNJ19939M, UDI/DI (EA)10193489393248, UDI/DI (CS)40193489393249 l) Model Number DYNJ24225K, UDI/DI (EA)10889942510702, UDI/DI (CS)40889942510703 m) Model Number DYNJ28067G, UDI/DI (EA)10889942744299, UDI/DI (CS)40889942744290 n) Model Number DYNJ33457C, UDI/DI (EA)10193489461800, UDI/DI (CS)40193489461801 o) Model Number DYNJ33638K, UDI/DI (EA)10193489343281, UDI/DI (CS)40193489343282 p) Model Number DYNJ34361, UDI/DI (EA)10884389348475, UDI/DI (CS)40884389348476 q) Model Number DYNJ36049, UDI/DI (EA)10884389498675, UDI/DI (CS)40884389498676 r) Model Number DYNJ37665B, UDI/DI (EA)10889942969739, UDI/DI (CS)40889942969730 s) Model Number DYNJ40632C, UDI/DI (EA)10193489461176, UDI/DI (CS)40193489461177 t) Model Number DYNJ41553D, UDI/DI (EA)10889942811335, UDI/DI (CS)40889942811336 u) Model Number DYNJ41649F, UDI/DI (EA)10193489641271, UDI/DI (CS)40193489641272 v) Model Number DYNJ42499C, UDI/DI (EA)10195327030865, UDI/DI (CS)40195327030866 w) Model Number DYNJ42903B, UDI/DI (EA)10888277798014, UDI/DI (CS)40888277798015 x) Model Number DYNJ43661B, UDI/DI (EA)10889942808700, UDI/DI (CS)40889942808701 y) Model Number DYNJ44293D, UDI/DI (EA)10193489833416, UDI/DI (CS)40193489833417 z) Model Number DYNJ44320F, UDI/DI (EA)10193489435511, UDI/DI (CS)40193489435512 aa) Model Number DYNJ45007, UDI/DI (EA)10888277085411, UDI/DI (CS)40888277085412 bb) Model Number DYNJ46043F, UDI/DI (EA)10193489856729, UDI/DI (CS)40193489856720 cc) Model Number DYNJ46153B, UDI/DI (EA)10193489853643, UDI/DI (CS)40193489853644 dd) Model Number DYNJ47004C, UDI/DI (EA)10193489696172, UDI/DI (CS)40193489696173 ee) Model Number DYNJ47226A, UDI/DI (EA)10888277561816, UDI/DI (CS)40888277561817 ff) Model Number DYNJ47906, UDI/DI (EA)10888277528376, UDI/DI (CS)40888277528377 gg) Model Number DYNJ47951A, UDI/DI (EA)10193489609844, UDI/DI (CS)40193489609845 hh) Model Number DYNJ49884F, UDI/DI (EA)10193489469578, UDI/DI (CS)40193489469579 ii) Model Number DYNJ50624A, UDI/DI (EA)10889942474639, UDI/DI (CS)40889942474630 jj) Model Number DYNJ51239A, UDI/DI (EA)10889942493548, UDI/DI (CS)40889942493549 kk) Model Number DYNJ52121, UDI/DI (EA)10889942243624, UDI/DI (CS)40889942243625 ll) Model Number DYNJ52898C, UDI/DI (EA)10193489876314, UDI/DI (CS)40193489876315 mm) Model Number DYNJ55252B, UDI/DI (EA)10193489870152, UDI/DI (CS)40193489870153 nn) Model Number DYNJ57498, UDI/DI (EA)10889942745746, UDI/DI (CS)40889942745747 oo) Model Number DYNJ57645B, UDI/DI (EA)10193489828658, UDI/DI (CS)40193489828659 pp) Model Number DYNJ57760B, UDI/DI (EA)10193489342581, UDI/DI (CS)40193489342582 qq) Model Number DYNJ57792A, UDI/DI (EA)10193489530896, UDI/DI (CS)40193489530897 rr) Model Number DYNJ57792B, UDI/DI (EA)10193489845945, UDI/DI (CS)40193489845946 ss) Model Number DYNJ58126A, UDI/DI (EA)10193489484755, UDI/DI (CS)40193489484756 tt) Model Number DYNJ59465B, UDI/DI (EA)10193489470932, UDI/DI (CS)40193489470933 uu) Model Number DYNJ60319A, UDI/DI (EA)10193489276299, UDI/DI (CS)40193489276290 vv) Model Number DYNJ60507A, UDI/DI (EA)10193489830552, UDI/DI (CS)40193489830553 ww) Model Number DYNJ61015B, UDI/DI (EA)10193489368888, UDI/DI (CS)40193489368889 xx) Model Number DYNJ62299, UDI/DI (EA)10193489641516, UDI/DI (CS)40193489641517 yy) Model Number DYNJ62379, UDI/DI (EA)10193489651706, UDI/DI (CS)40193489651707 zz) Model Number DYNJ62544, UDI/DI (EA)10193489666526, UDI/DI (CS)40193489666527 aaa) Model Number DYNJ62742, UDI/DI (EA)10193489685923, UDI/DI (CS)40193489685924 bbb) Model Number DYNJ63976A, UDI/DI (EA)10193489377965, UDI/DI (CS)40193489377966 ccc) Model Number DYNJ64830, UDI/DI (EA)10193489223132, UDI/DI (CS)40193489223133 ddd) Model Number DYNJ65043A, UDI/DI (EA)10193489379327, UDI/DI (CS)40193489379328 eee) Model Number DYNJ65185, UDI/DI (EA)10193489253146, UDI/DI (CS)40193489253147 fff) Model Number DYNJ65190C, UDI/DI (EA)10193489433111, UDI/DI (CS)40193489433112 ggg) Model Number DYNJ65482A, UDI/DI (EA)10193489416824, UDI/DI (CS)40193489416825 hhh) Model Number DYNJ66398B, UDI/DI (EA)10193489891928, UDI/DI (CS)40193489891929 iii) Model Number DYNJ66476, UDI/DI (EA)10193489356779, UDI/DI (CS)40193489356770 jjj) Model Number DYNJ66500, UDI/DI (EA)10193489357912, UDI/DI (CS)40193489357913 kkk) Model Number DYNJ67245, UDI/DI (EA)10193489393057, UDI/DI (CS)40193489393058 lll) Model Number DYNJ68065A, UDI/DI (EA)10193489888720, UDI/DI (CS)40193489888721 mmm) Model Number DYNJ68758, UDI/DI (EA)10193489837568, UDI/DI (CS)40193489837569 nnn) Model Number DYNJ902507B, UDI/DI (EA)10889942781188, UDI/DI (CS)40889942781189 ooo) Model Number DYNJC2371G, UDI/DI (EA)10889942494675, UDI/DI (CS)40889942494676 ppp) Model Number DYNJT2344B, UDI/DI (EA)10889942107803, UDI/DI (CS)40889942107804 qqq) Model Number PHS41743D, UDI/DI (EA)10193489453270, UDI/DI (CS)40193489453271
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.