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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85022

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

Open FDA event record

Event summary

Timeline bucket
February 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries Inc

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 Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

Z-1544-2020
Recall number
Z-1544-2020
Initiated
February 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1,541,532 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Code information

REF DYND70288 2/PK Expiration 06/30/2022

Distribution pattern

US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

device · product 2 of 3

Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.

Z-1545-2020
Recall number
Z-1545-2020
Initiated
February 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
117,874 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Code information

REF DYND70289 Expiration 06/30/2022

Distribution pattern

US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

device · product 3 of 3

Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.

Z-1546-2020
Recall number
Z-1546-2020
Initiated
February 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
3,690 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Code information

REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153

Distribution pattern

US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.