Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
URINE COLLECTION KIT, SKU DYKM1848A
DYKM2005
DYKM2151
DYLAB1004
DYLAB1004A
DYLAB1006
DYLAB1012
; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0358-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0359-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
URINE KIT, SKU DYKM1845; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0360-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 23, 2024
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Root cause: Under Investigation by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.Recall #Z-0361-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Sep 17, 2024
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and
management of digital images, patient data, diagnostic data and clinical information from Topcon devices.
It is intended for processing and displaying ophthalmic images and optical coherence tomography data.
The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known
normal subjects.
Reason: The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood
Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
Root cause: Software design
Recalling firm: Topcon Medical Systems, Inc.Type: System, Image Management, OphthalmicDistribution: US Nationwide distribution.Recall #Z-0362-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Oct 21, 2024
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10
Tubing Set, Irrigation, PC
Reason: Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
Root cause: Labeling design
Recalling firm: Karl Storz EndoscopyType: Tubing And Tubing/Filter FitsDistribution: U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.Recall #Z-0363-2025
Open, ClassifiedPosted Nov 12, 2024·Initiated Sep 11, 2024
Brand Name: UroPass Ureteral Access Sheaths
Product Name: Ureteral Access Sheaths
Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX
Software Version: N/A
Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only.
Component: N/A
Reason: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
Root cause: Storage
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Catheter, G-UDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.Recall #Z-0364-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Sep 25, 2024
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Reason: Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Root cause: Under Investigation by firm
Recalling firm: Cardinal Health 200, LLCType: Syringe, AntistickDistribution: NationwideRecall #Z-0310-2025 Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 4, 2024
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Reason: A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Root cause: Process change control
Recalling firm: FHC, Inc.Type: Neurological Stereotaxic InstrumentDistribution: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.Recall #Z-0312-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Jul 11, 2022
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Reason: When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved.
Root cause: Device Design
Recalling firm: WISSNER-BOSSERHOFF GMBHType: Bed, Therapeutic, Ac-Powered, Adjustable Home-UseDistribution: US Nationwide distribution in the states of NC.Recall #Z-0329-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0330-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0331-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0332-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0333-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0334-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0335-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0336-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0337-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0338-2025
Open, ClassifiedPosted Nov 8, 2024·Initiated Oct 9, 2024
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Reason: A limited number of IV bags have been found to leak during filling.
Root cause: Under Investigation by firm
Recalling firm: The Metrix CompanyType: Container, I.V.Distribution: Worldwide - US Nationwide distribution in the states of TX, IL, OH, PA, WA, MD, IL, UT, CA, MA, PA, MI, FL, PR, and the country of Canada.Recall #Z-0339-2025