Agency classClass IIOur severity:High FDA (Devices)·Z-1699-2023·Announced 2023-06-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Intermittent Urinary Catheter
Hazard: manufacturing-defect
sterility-risk
Affected units: 7,427,880

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.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · C.R. Bard Inc

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Same hazard · manufacturing defect