Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 26, 2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP - Northfield recalled Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a… - a moderate-severity action.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a… was recalled by Medline Industries, LP - Northfield in July 26, 2023. Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Check the official notice for the remedy. Verify recall #Z-2180-2023 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams..
- Moderate
- severity level
- Class II
- classification
- July 26, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2180-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2180-2023) was formally reported on July 26, 2023, with the manufacturer initiating the action on May 18, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as # included in 3,740,814 units total.
The documented reason for this recall is: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
# included in 3,740,814 units total
Related Recalls
6
6 from same agency
Product description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2180-2023 |
| Date reported | July 26, 2023 |
| Date initiated | May 18, 2023 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | # included in 3,740,814 units total |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2180-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg. Recalled by Medline Industries, LP - Northfield. Units affected: # included in 3,740,814 units total.
Why was this product recalled? ▼
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2180-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2180-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 26, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.