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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97027

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 23, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.

Z-2043-2025
Recall number
Z-2043-2025
Initiated
May 23, 2025
Classification
Class II
Status
Ongoing
Quantity
186 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

Code information

1) REF ACC010254B: UDI/DI 10193489651683 (each), 40193489651684 (case), Lot Number: 24LDA269; 2) REF ACC010256: UDI/DI 10884389559529 (each), 40884389559520 (case), Lot Number: 24LDA106; 3) REF ACC010316A: UDI/DI 10889942831746 (each), 40889942831747 (case), Lot Number: 24LDA823; 4) REF ACC010389C: UDI/DI 10193489472493 (each), 40193489472494 (case), Lot Number: 24LDB092; 5) REF ACC010627: UDI/DI 10195327226589 (each), 40195327226580 (case), Lot Number: 24LDA268; 6) REF ACC010898: UDI/DI 10198459192074 (each), 40198459192075 (case), Lot Number: 24LDA260.

Distribution pattern

US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

device · product 2 of 3

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665

Z-2044-2025
Recall number
Z-2044-2025
Initiated
May 23, 2025
Classification
Class II
Status
Ongoing
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

Code information

1) REF ACC010665: UDI/DI 10195327334918 (each), 40195327334919 (case), Lot Number 24LDA590

Distribution pattern

US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

device · product 3 of 3

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B

Z-2045-2025
Recall number
Z-2045-2025
Initiated
May 23, 2025
Classification
Class II
Status
Ongoing
Quantity
80 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

Code information

1) REF DYNJ0151148B: UDI/DI 10889942050819 (each), 40889942050810 (case), Lot Number 24LDA980

Distribution pattern

US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

Field note

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