PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency
Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a subpotency/out-of-specification manufacturing defect. No illnesses, injuries, or deaths are reported in the source text. The hazard is the reduced efficacy of an antiseptic product, which is a quality and effectiveness issue rather than an acute safety threat, supporting a Moderate severity classification.
Plain-English summary
Professional Disposables International, Inc. is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks (also packaged as Step 1 Scrub and Step 2 Prep variants) distributed nationwide in the United States. The products are affected by a subpotency issue, meaning the povidone-iodine active ingredient is out of specification and below the required strength.
The affected products include approximately 11,039 cases with specific NDC and lot numbers. The recall affects healthcare and professional settings where these swabsticks are used for skin cleansing and preparation prior to medical procedures. When the active ingredient is subpotent, the product may not provide the intended antiseptic protection.
Consumers and healthcare providers who have received this product should discontinue use and contact Professional Disposables International for instructions on product return or replacement. For further information, healthcare facilities should review their product inventory against the specific lot numbers identified in this recall.
The recalled product
- Product
- PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
- Manufacturer
- Professional Disposables International, Inc
- Hazard
- subpotency
- out-of-specification
- reduced-efficacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- SKU S23125 Lot #'s 11900971
- 11901517
- 11901756
- 12000199
- 12000286
- 12000459
- 12000686
- 12000751
- 12001009
- 12001316
- 12001795
- 12001809
- 12001862
- 12001863
- 12002140
- 12002141
- 12100392 and 12100393
Distribution
Distributed nationwide across the United States.
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