CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Ultra Fabric Reinforced surgical Gown X-Large Sterile recalled
Kimberly-Clark is recalling Ultra Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single, distributed nationwide in the US. The recall was initiated on 5 Jul 2012 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-0257-2013
- FDA event ID
- 63598
- Recalling firm
- Kimberly-Clark, Roswell, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2012
- FDA classified
- 7 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 5 Jul 2012 | Recall initiated by company | |
| 7 Nov 2012 | Classified by FDA | +125 days |
| 14 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Which lots are affected?
Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146***
Where was it sold?
Nationwide Distribution
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
1 other product · FDA event 63598This product is part of a recall event; the main page for the event is MicroCool Breathable Gown with Towels, X-Larg, X-Long recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MicroCool Breathable Gown with Towels, X-Larg, X-Long recalled | Kimberly-Clark | Sterility | Nationwide |
More recalls from Kimberly-Clark
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Scott¿ Moisturizing Foam Hand Sanitizer recalled by Kimberly-Clark | Kimberly-Clark | Labeling Errors | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular/Super Tampons Multipack recalled | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |