Z-2284-2025Class II

Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium...

Name: Z-2284-2025 Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium...
Creator: Carefree Surgical Specialties
Published: 2025-07-01
License: https://open.fda.gov/license/

Carefree Surgical Specialties, Inc. / initiated 2025-07-01 / Open, Classified / root cause: manufacturing process

FDA source

Carefree Surgical Specialties began a recall of Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes... on 2025-07-01. FDA classified it as Class II and gives the reason as "Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2284-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-01
Posted: 2025-08-08
Recalling firm: Carefree Surgical Specialties, Inc.
Product: Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 07/9/2025 and 07/14/2025, the firm send via email and certified mail an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter to customers informing them of two product issues: 1. the potential presence of foreign matter contamination within some units. 2. packaging discrepancy involving the number of gauze packs contained within sealed units. Customers are instructed to: For Issue 1: 1. Discontinue Use: Discontinue use of any unopened packages of SKU 15506/25 from Lots 1607. 2.Report any findings: Report any findings to Carefree Surgical using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. For Issue 2: 1.Inspect their inventory: Visually check all unopened packages of SKU 15508/25 from Lots 1595 and SKU 15505/25 from Lots 1645 and 1650 to confirm each contains five (5) sterile gauze rolls 2.Report any discrepancies: If any units contain more than 5 rolls, please notify us immediately using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. Any questions or need assistance with returns or replacements, please contact: Attn: Sarah Monroe Carefree Surgical Specialties, Inc. (916)663-4082 or [email protected]
Quantity in commerce: 65
Distribution: 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.
Product codes and lots: Lot Code: Lot Number: 1607 UDI Code: Not Available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2282-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2283-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08
Z-2284-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08

Product code GDY

K882708Class IGauze Sponge, X-Ray DetectableBioseal / cleared 1988-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)