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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Medline Industries Inc: Povidone-Iodine Prep Pads and Medical Kits Recalled for Low Iodine Content

Agency Publication Date: February 1, 2018
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Summary

Medline Industries Inc. is recalling approximately 560,893 units of Aplicare Povidone-Iodine Prep Pads and various medical procedure kits containing these pads. These antiseptic pads were found to be subpotent, meaning the level of titratable iodine is below the required label claim of 0.85%. The affected products include stand-alone antiseptic pads and specialized kits for IV starts, suture removal, catheter insertion, and various surgeries sold nationwide and internationally.

Risk

Because the iodine level is lower than specified, the antiseptic pads may not effectively kill bacteria or prevent infection as intended during medical procedures. This poses a risk of infection to patients, particularly when used for wound care, surgical preparation, or catheter insertion.

What You Should Do

  1. Check your medical supplies for Aplicare Povidone-Iodine Prep Pads or Medline procedure kits, such as Suture Removal Trays, IV Start Kits, or Catheter Insertion Kits.
  2. Verify the Lot Numbers and Part Numbers against the extensive list provided in the recall notice, which includes hundreds of specific lot codes such as 58471, 17GB6098, and 17SB5603.
  3. Identify the affected products by checking for specific Pack Numbers like DYND70900 (Suture Removal Tray), DYND74077 (IV Start Kit), or MDS708555 (Suture Removal Tray).
  4. Stop using any affected prep pads or medical kits immediately to avoid the risk of ineffective disinfection.
  5. Contact your healthcare provider or pharmacist for guidance if you have recently used these products for wound care or during a medical procedure.
  6. Return any unused recalled products to the place of purchase for a refund and contact Medline Industries at 1-800-633-5463 for further instructions on returning or replacing the goods.
  7. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare guidance and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution (10%)
Model:
P-1001
P-1001-8S
P-1011
P-1011-8S
Lot Numbers (76):
58471
59003
59723
60373
60807
61187
61523
61998
63974
64701
65864
58368
58371
58472
58499
58686
58687
58688
58816
58817
58818
59002
59004
59333
59334
59335
59574
59724
59725
60157
60237
60374
60375
60507
60586
61101
61368
61427
61618
61750
61751
61999
62067
62224
62226
62557
62558
62954
62955
63441
Product: Medline CC Drawer 4 IV Circulation Pack
Model:
ACC010254A
Lot Numbers:
17HD4376
17HD1709
Product: Medline Vaginal Delivery CDS Pack
Model:
CDS830006I
Lot Numbers:
17IB3974
Product: Medline Vitrectomy CDS Pack
Model:
CDS984258F
Lot Numbers:
177B1083
Product: Medline Suture Removal Tray
Model:
DYND70900
DYND70900H
MDS701550
MDS708550
MDS708555
SD-1010
Z302-R
Lot Numbers:
17GB6098
16KB8714
17GB5103
17EB4268
17BB3409
17SB1821
17OB8226
16QB7895
17EB7214
16LB5336
17QB4767
17MB3722
17PB7167
17EB0363
17DB2103
17FB2572
16WB5947
16SB7791
16TB0404
Product: Medline IV Start Kit
Model:
DYND74077
DYND74077H
DYNDV1609
Lot Numbers:
16GB2754
17GB3103
16IB7722
17EB6063
17GB1216
Product: Liberator Medical Supply Catheter Insertion Tray
Model:
DYNDT1022E
Lot Numbers:
17QB4402
17TB1979
Product: Medical Equipment Affiliates IV Start Kit
Model:
DYNDV39010
Lot Numbers:
17QB8612

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78575
Status: Resolved
Manufacturer: Medline Industries Inc
Sold By: Liberator Medical Supply, INC.; Medical Equipment Affiliates; Professional Hospital Supply, Inc.; specialty retailers; hospitals; medical supply distributors
Manufactured In: United States, Mexico
Units Affected: 67 products (11,750 cases; 51 cases; 2 cases; 5 cases; 4 cases; 288 cases; 21 cases; 51 cases; 50 cases; 375 cases; 231 cases; 1,000 cases; 65,563 cases; 10,375 cases; 14,675 cases; 11 cases; 40 cases; 40 cases; 80 cases; 700 cases; 363 cases; 280 cases; 60 cases; 80 cases; 4,100 cases; 250 cases; 56 cases; 600 cases; 700 cases; 1100 cases; 248 cases; 80 cases; 1,133 cases; 3800 cases; 600 cases; 3,089 cases; 346 cases; 700 cases; 550 cases; 10,298 cases; 100 cases; 100 cases; 1,250 cases; 3,300 cases; 20,430 cases; 2,336 cases; 350 cases; 5,400 cases; 90 cases; 120 cases; 2,369 cases; 66 cases; 88 cases; 149 cases; 60 cases; 49,587 cases; 808 cases; 98,901 cases; 195,448 cases; 450 cases; 663 cases; 779 cases; 592 ases; 144 cases; 9,000 cases; 34,495 cases; 73 cases)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.