CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Medline convenience kits containing Bard¿ Silastic¿ Foley recalled
Medline Industries is recalling Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2782-2026
- FDA event ID
- 99301
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jun 2026
- FDA classified
- 23 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jun 2026 | Recall initiated by company | |
| 23 Jul 2026 | Classified by FDA | +45 days |
| 29 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Product as listed by the FDA
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
Where it was distributed
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
Questions about this recall
Why was it recalled?
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Which lots are affected?
DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203
Where was it sold?
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 99301This product is part of a recall event; the main page for the event is Medline convenience kits containing Bard¿ Silastic¿ Foley recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide | |
| CLASS II | Medline convenience kits containing Bard¿ Silastic¿ Foley recalled | Medline Industries | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
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| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |