Magic3 Go Intermittent Urinary Catheters Recalled for Packaging Defect
C.R. Bard is recalling Magic3 Go Intermittent Urinary Catheters because the clear resealing label can separate from the pouch, potentially compromising sterility. The recall affects devices distributed worldwide.
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 recall with no reported illnesses or injuries. The hazard is theoretical—a potential compromise to product sterility—without confirmed cases of harm. Per the severity rubric, this qualifies as High (3): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
C.R. Bard Inc is recalling Magic3 Go Intermittent Urinary Catheters (male) due to a manufacturing defect affecting the clear resealing label on the foil pouch. In some units, this label has separated from the pouch, creating a possible opening that could compromise the sterility of the catheter. Approximately 7.4 million devices distributed worldwide are affected by this recall.
The separation allows a potential breach of the product's sterile packaging. Since these devices are intended for internal use, any compromise to sterility could present a health risk.
Affected devices are identified by specific catalog numbers and lot numbers. Healthcare facilities and patients should check their inventory against the official FDA recall notice. Contact C.R. Bard Inc or the FDA for specific lot numbers and guidance.
The recalled product
- Product
- Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
- Manufacturer
- C.R. Bard Inc
- Hazard
- manufacturing-defect
- sterility-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 (20)
- a) REF 50810G
- UDI/DI 0 801741137006
- Lot Numbers: JUGV1658
- b) REF 50812G
- UDI/DI 0 801741137013
- Lot Numbers: JUGU0844
- JUGV1290
- JUGW9017
- c) REF 50814G
- UDI/DI 0 801741137020
- Lot Numbers: JUGS1485
- JUGT0238
- JUGT0980
- JUGT1000
- JUGT1710
- JUGT2735
- JUGT3299
- JUGT3353
- JUGU0874
- JUGU1917
Distribution
Distribution scope not specified by the agency.
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