Cesarean Birth Drapes recalled due to defective plastic film causing sticking
Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall where a manufacturing defect prevents proper unfolding and application of surgical drapes used in cesarean surgery. While the defect creates a risk of compromised sterile field, the source text reports no injuries or illnesses, making this a risk-of-harm product without reported harm.
Plain-English summary
Cardinal Health 200, LLC is recalling Nonsterile Sterile Cesarean Birth Drapes with Dual Layer Anesthesia Screen (Catalog Number 29442N) due to a defect in the plastic film used to manufacture the product. The defect causes the drapes to stick together, which may prevent the drapes from being unfolded and applied properly during use.
The affected drapes were distributed nationwide in both single sterile and bulk non-sterile configurations. A total of 6,461 units are included in this recall. The affected lot numbers are: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, and 3570QR2.
Cesarean birth drapes are intended to isolate the surgical incision site from contamination during surgery. If drapes cannot be properly unfolded and applied, the sterile field may be compromised. If you have these drapes in stock, stop using them and contact Cardinal Health 200, LLC to arrange for return or replacement.
The recalled product
- Product
- Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drape
- Hazard
- manufacturing-defect
- improper-deployment
- contamination-risk
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 (14)
- Lot Numbers: 0121QR2
- 0391RR1
- 3070QR1
- 3280QR1
- 3280QR2
- 3290QR1
- 3290QR2
- 3300QR1
- 3300QR2
- 3310QR1
- 3310QR2
- 3320QR1
- 3570QR1
- 3570QR2
Distribution
Distributed nationwide across the United States.
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