ModerateClass IIOngoing

FDA Devices recall · Reported October 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PAC

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0174-2025.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0174-2025) 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.

Q: 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.

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal…

Recall #: Z-0174-2025
Affected scope: 12,583 units
Initiated: September 4, 2024

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

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Medline Industries, LP - Northfield recalled Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYN… — a moderate-severity action.

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYN… was recalled by Medline Industries, LP - Northfield in October 30, 2024. Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may r…. Check the official notice for the remedy. Verify recall #Z-0174-2025 with the FDA Devices before acting.

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The recall

Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may r….

Moderate
severity level: 13K units
affected scope: Class II
classification: October 30, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0174-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0174-2025) was formally reported on October 30, 2024, with the manufacturer initiating the action on September 4, 2024. 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 12,583 units.

The documented reason for this recall is: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Panama.. 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.

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.

Severity

Moderate

Affected scope

12,583 units

Related Recalls

6 from same agency

Product description

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B; 25) OB DELIVERY PACK, REF DYNJ41994; 26) DELIVERY BUNDLE KIT, REF DYNJ43370A; 27) DELIVERY ROOM PACK, REF DYNJ44328G; 28) OB PACK, REF DYNJ44500F; 29) DELIVERY PACK, REF DYNJ47621A; 30) OB PACK, REF DYNJ50482G; 31) DELIVERY PACK, REF DYNJ52966C; 32) DELIVERY PACK, REF DYNJ57567; 33) LABOR & DELIVERY PACK, REF DYNJ57598; 34) OB DELIVERY PACK, REF DYNJ60784B; 35) VAGINAL DELIVERY PACK, REF DYNJ61662; 36) VAGINAL DELIVERY PACK, REF DYNJ61662; 37) LABOR AND DELIVERY PACK, REF DYNJ61864A; 38) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 39) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 40) VUWC OB PACK, REF DYNJ64017B; 41) OB PACK, REF DYNJ65525B; 42) VAG DELIVERY PACK, REF DYNJ66415; 43) VAGINAL DELIVERY PACK, REF DYNJ66970; 44) VAG DELIVERY, REF DYNJ67089; 45) VAGINAL DELIVERY PACK, REF DYNJ67111; 46) VAGINAL DELIVERY PACK, REF DYNJ67111; 47) AOMC MIDWIFE PACK, REF DYNJ67588; 48) VAGINAL DELIVERY TRAY, REF DYNJ68131A; 49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C; 50) DELIVERY L & D PACK, REF DYNJ68251D; 51) DELIVERY L & D PACK, REF DYNJ68251D; 52) SS VAGINAL DELIVERY PACK, REF DYNJ69512; 53) VAGINAL DELIVERY PACK, REF DYNJ69544A; 54) DELIVERY, REF DYNJ69721; 55) VAGINAL PACK, REF DYNJ69774A; 56) LABOR & DELIVERY PACK, REF DYNJ69833; 57) VAGINAL DELIVERY, REF DYNJ80532A; 58) OB PACK, REF DYNJ81878; 59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917; 60) GENERAL DELIVERY PACK, REF DYNJ82447; 61) VAGINAL DELIVERY PACK, REF DYNJ82489B; 62) OB PACK, REF DYNJ82923; 63) OB PACK III, REF DYNJ82945; 64) OB PACK, REF DYNJ83196; 65) OB PACK, REF DYNJ83515; 66) 3027240 OB DELIVERY PACK, REF DYNJ84730; 67) DELIVERY PACK, REF DYNJ85860; 68) LABOR AND DELIVERY, REF DYNJ907794A; 69) LABOR AND DELIVERY, REF DYNJ907794A; 70) LABOR AND DELIVERY, REF DYNJ907794A; 71) VAGINAL DELIVERY, REF DYNJ908636A; 72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G; 73) PACK VAGINAL DELIVERY, REF HM190A; 74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D; 75) VAGINAL DELIVERY PACK, REF SYNJ10248B; 76) VAGINAL DELIVERY PACK, REF SYNJ10248B

Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0174-2025
Date reported	October 30, 2024
Date initiated	September 4, 2024
Recalling firm	Medline Industries, LP - Northfield
Firm location	Northfield, IL
Affected scope	12,583 units
Distribution	Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

12,583 units units affected — limited or regional distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0174-2025) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0174-2025.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0174-2025) 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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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 30, 2024.

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.