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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 Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Sterile PVP Solutions and Prep Sticks Recalled for Non-Sterile Contents

Agency Publication Date: December 11, 2023
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Summary

Medline Industries is recalling 13,340 units of various povidone-iodine (PVP) solutions, prep sticks, and kits because the contents inside the foil sachets are non-sterile, despite the labeling stating they are sterile. The recall includes specific lots of Sterile PVP Solution, PVP SLN Kits, Prep Sticks, Betadine, and Povidone products distributed across several states. Using a non-sterile solution in a procedure that requires a sterile environment can lead to serious infections, especially in clinical settings.

Risk

The contents of the solution sachets were found to be non-sterile, which poses a significant risk of infection to patients. If these products are used for surgical site preparation or wound care, bacteria or other microorganisms in the solution could be introduced directly into the body.

What You Should Do

  1. Check your medical supplies for the following Medline products: Sterile PVP Solution (REF DYNDA1907), Sterile PVP SLN Kit (REF DYNDM1097), Sterile Prep Stick (REF DYNDA1134), Sterile PVP (REF DYNDA1649), PVP Solution Sing Strl (REF DYNDA1858), Sterile Betadine (REF DYNDA1998), or Sterile Povidone (REF DYNDA2061).
  2. Verify the lot numbers on your packaging against the affected list, which includes lots such as 22LBL675, 21GBJ087, 2023082190, 2022060190, 2023032090, 2023042190, and 2022040790 among others.
  3. Immediately stop using any affected products that match the identified lot numbers and reference numbers.
  4. Contact your healthcare provider if you believe an affected product was used during a procedure and you are experiencing signs of infection.
  5. Contact Medline Industries, LP directly at their Northfield, Illinois headquarters or via the contact information provided on their website (www.medline.com) for instructions on returning the product and receiving a replacement or credit.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Cease use and contact the manufacturer for further instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: STERILE PVP SOLUTION, REF DYNDA1907
Model / REF:
REF DYNDA1907
UPC Codes:
40889942574491
10889942574490
Lot Numbers:
22LBL675
22JBR599
22IBS045
22GBT655
22DBN398
22DBD250
22DBA001
21LBN032
21JBA478
21EBE405
Product: STERILE PVP SLN KIT, REF DYNDM1097
Model / REF:
REF DYNDM1097
UPC Codes:
40884389601892
10884389601891
Lot Numbers:
21GBJ087
Product: STERILE STERILE PREP STICK, REF DYNDA1134
Model / REF:
REF DYNDA1134
UPC Codes:
40888277098023
10888277098022
Lot Numbers:
2023082190
Product: STERILE PVP, REF DYNDA1649
Model / REF:
REF DYNDA1649
UPC Codes:
40889942326519
10889942326518
Lot Numbers:
2022060190
2022021590
Product: PVP SOLUTION SING STRL, REF DYNDA1858
Model / REF:
REF DYNDA1858
UPC Codes:
40889942539858
10889942539857
Lot Numbers:
2023032090
2023020990
2022103190
2022091690
2022070190
2022052090
2022042290
2022033190
2021102290
2021092190
Product: STERILE BETADINE, REF DYNDA1998
Model / REF:
REF DYNDA1998
UPC Codes:
40889942651062
10889942651061
Lot Numbers:
2023042190
2022101090
2022081590
2022041390
2022031090
2022011290
2021100490
Product: STERILE POVIDONE, REF DYNDA2061
Model / REF:
REF DYNDA2061
UPC Codes:
40889942697633
10889942697632
Lot Numbers:
2022040790
2022062190

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93395
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 7 products (8250 units; 100 units; 240 units; 700 units; 1950 units; 1800 units; 300 units)
Distributed To: Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, Florida

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.