Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 9, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g.
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP - Northfield recalled Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labele… - a moderate-severity action.
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labele… was recalled by Medline Industries, LP - Northfield in August 9, 2023. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.. Check the official notice for the remedy. Verify recall #Z-2296-2023 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..
- Moderate
- severity level
- Class II
- classification
- August 9, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2296-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2296-2023) was formally reported on August 9, 2023, with the manufacturer initiating the action on May 15, 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 63,823 kits.
The documented reason for this recall is: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.. 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
63,823 kits
Related Recalls
6
6 from same agency
Product description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG
Reason for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2296-2023 |
| Date reported | August 9, 2023 |
| Date initiated | May 15, 2023 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 63,823 kits |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. |
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-2296-2023) 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? ▼
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ902507B; b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F; c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N; d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F; e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A; f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C; g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B; h. ANGIO PACK 2-A, Model Number: DYNJ60507A; i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M; j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121; k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; l. ANGIO/PICC PACK, Model Number: DYNJ36049; m. ANGIOGRAM, Model Number: DYNJ0149444M; n. ANGIOGRAM PACK, Model Numbers: DYNJ45007, DYNJ47004C, DYNJ66244; o. ANGIOGRAM TRAY, Model Number: DYNJ33638K; p. ANGIOGRAPHY DRAPE PACK, Model Numbers: DYNJ49621B, DYNJ63060A, DYNJ63684F, DYNJ68065, DYNJ68065A, DYNJT2344B; q. ANGIOGRAPHY DRAPE PACK-LF, Model Numbers: DYNJ28067G, DYNJVB1135A; r. ANGIOGRAPHY DRP PK PEDI CATH, Model Numbers: 00-401318L, 00-401318M; s. ANGIOGRAPHY OR, Model Number: CDS984944C; t. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293D, DYNJ47906, DYNJ55252B, DYNJ57498, DYNJ65190C, DYNJ66476, DYNJC2371G; u. ANGIOGRAPHY PACK-LF, Model Number: DYNJ0854485T; v. ANGIOPLASTY PACK-LF, Model Numbers: DYNJ43203F, DYNJ64655A; w. CATH LAB PACK, Model Number: DYNJ65185; x. CLOVIS CATH LAB PACK, Model Number: DYNJ62379; y. CUSTOM ANGIO TRAY, Model Number: DYNJ41649F; z. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367A; aa. DASHTI-YAO NEURO ANGIO-LF, Model Number: DYNJ33457C; bb. DBD-ANGIO TRAY, Model Number: DYNJ68758; cc. DBD-CATH PACK, Model Number: DYNJ63527; dd. DBD-CLOVIS CATH LAB PACK, Model Number: DYNJ62379; ee. DEPAUL ANGIO PACK, Model Number: DYNJ19939M; ff. EH VASCULAR ANGIO, Model Number: DYNJ49931F; gg. ENDOVASCULAR KIT, Model Number: DYNJ906354C; hh. EP ANGIOGRAPHY PACK, Model Number: DYNJ24225K; ii. FEMORAL ANGIOGRAPY SET UP, Model Number: DYNJ61015B; jj. FS ANGIO, Model Number: DYNJ42499C; kk. GENERAL ANGIO PACK, Model Number: DYNJ57760B; ll. HH ANGIO PACK, Model Number: DYNJ59465B; mm. IPMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0806254D; nn. IR MINOR ANGIO PACK, Model Number: DYNJ37665B; oo. KENNESTONE ANGIO, Model Number: WK100B; pp. MH HOOD CARDIAC ANGIO, Model Numbers: DYNJ49884B, DYNJ49884F; qq. MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553D; rr. OR ANGIO PACK, Model Number: DYNJ60319A; ss. OR ANGIOGRAPHY PACK, Model Number: DYNJ67245; tt. PACK,BASIC ANGIO, Model Number: DYNJ65482A; uu. PEDI ANGIO PACK-LF, Model Number: PHS41743D; vv. PEDIATRIC CATH ANGIO PACK, Model Numbers: DYNJ54755D, DYNJ54755F; ww. PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112; xx. PERCUTANEOUS ANGIO PACK-LF, Model Numbers: DYNJ57645A, DYNJ57645B; yy. PORT PACK, Model Number: DYNJ61747A; zz. SUNSHINE PACK, Model Number: DYNJ64830; aaa. SURGERY ANGIO PACK-LF, Model Number: DYNJ66500; bbb. VASCULAR ANGIO PACK-LF, Model Numbers: DYNJ0201109AG. Recalled by Medline Industries, LP - Northfield. Units affected: 63,823 kits.
Why was this product recalled? ▼
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2296-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2296-2023) 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 August 9, 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.