Applicator, Absorbent Tipped, Sterile
General Hospital · 21 CFR 880.6025
Recent MDR events
813 adverse event reports on file
- MEDLINEJun 1, 2026MalfunctionMedline Industries, Lp1417592-2026-01986
- MEDLINEApr 24, 2026MalfunctionMedline Industries, Lp1417592-2026-00563
- 6 INCH COTTON TIPPED APPLICATORApr 14, 2026InjuryMedline Industries Lp - NorthfieldMW5186809
- BD STERILE CULTURE SWABNov 24, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-05464
- APPLICATOR,COTTON-TIP,WOOD,6,STRLOct 10, 2025InjuryMedline Industries, Lp1417592-2025-00540
- APPLICATOR,COTTON-TIP,PLASTIC,6,STERILESep 25, 2025InjuryMedline Industries, Lp1417592-2025-00509
- APPLICATOR,COTTON-TIP,WOOD,3,STRLAug 12, 2025MalfunctionMedline Industries Inc.1417592-2025-00380
- BD STERILE CULTURE SWABMay 2, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00342
- BD STERILE CULTURE SWABMay 2, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00343
- BD STERILE CULTURE SWABMay 2, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-00347
Event type breakdown
Recalls
10 recall events for this product code
- Puritan Medical Products Company, LlcOpen, ClassifiedMar 28, 2024
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Z-1391-2024 · View FDA record ↗ - LumiraDxOpen, ClassifiedJun 15, 2023
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area.
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
Z-1970-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0498-2023 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS)
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1633-2022 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1634-2022 · View FDA record ↗ - Copan ItaliaTerminatedSep 9, 2021
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Z-2440-2021 · View FDA record ↗ - Puritan Medical Products Co., LLCTerminatedMar 13, 2015
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT.
Shaft breaks so that adequate patient specimen sample cannot be obtained.
Z-1278-2015 · View FDA record ↗ - Fisher Scientific CoTerminatedApr 28, 2014
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack
A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.
Z-1521-2014 · View FDA record ↗ - Fisher Scientific CoTerminatedAug 12, 2013
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case.
The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
Z-1955-2013 · View FDA record ↗ - Merit Medical Systems, Inc.TerminatedUnknown
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Z-0454-2021 · View FDA record ↗
Registered firms
285 firms currently registered for this product code
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
V&q Manufacturing Corporation
Xiantao Hubei, CN
Menasha Packaging Company ,llc
EDISON, NJ, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Midwest Sterilization Corp.
LAREDO, TX, US
Tribest Dental Products Co Ltd
Yangzhong Jiangsu, CN
Puritan Medical Products, Llc
Pittsfield, ME, US
Applied Medical Distribution Center
Irvine, CA, US
Oketz Logistics Llc
Coral Gables, FL, US
Jiangsu Guangda Medical Material Group Co., Ltd.
Haian Jiangsu, CN
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Sterilization Services Of Virginia
RICHMOND, VA, US
Planet Holdings Limited
Hong Kong, HK
Synergy Health Ede Bv
Venlo Limburg, NL
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Diatrust Medical Co., Ltd.
Nanjing City Jiangsu, CN
Bioteke Corporation (wuxi) Co., Ltd
Wuxi City Jiangsu, CN
Gilero, Inc
Pittsboro, NC, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Ipb Inc
Ogden, UT, US
Azer Scientific, Inc.
Morgantown, PA, US
Isomedix Operations Inc
GROVEPORT, OH, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Carwild Corp.
NEW LONDON, CT, US
510(k) clearances
1 clearances for this product code