CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray recalled
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable/CS, distributed nationwide in the US. The recall was initiated on 1 Jul 2025 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-2283-2025
- FDA event ID
- 97259
- Recalling firm
- Carefree Surgical Specialties, Nampa, ID
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jul 2025
- FDA classified
- 8 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 1 Jul 2025 | Recall initiated by company | |
| 8 Aug 2025 | Classified by FDA | +38 days |
| 20 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS
Where it was distributed
US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontana
Questions about this recall
Why was it recalled?
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Which lots are affected?
Lot Code: Lot Number: 1650 UDI Code: Not Available
Where was it sold?
US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.
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
3 other products · FDA event 97259This product is part of a recall event; the main page for the event is Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray recalled | Carefree Surgical Specialties | Foreign Material | Nationwide | |
| CLASS II | Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long recalled | Carefree Surgical Specialties | Foreign Material | Nationwide | |
| CLASS II | Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray recalled | Carefree Surgical Specialties | Foreign Material | Nationwide |
More recalls from Carefree Surgical Specialties
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray recalled | Carefree Surgical Specialties | Foreign Material | Nationwide |
| Device | CLASS II | Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long recalled | Carefree Surgical Specialties | Foreign Material | Nationwide |
| Device | CLASS II | Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray recalled | Carefree Surgical Specialties | Foreign Material | Nationwide |
Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |