Open, ClassifiedPosted Apr 23, 2026·Initiated Mar 18, 2026
Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Reason: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Root cause: Labeling Change Control
Recalling firm: Diversatek HealthcareType: Dilator, EsophagealDistribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, BelgiumRecall #Z-1938-2026
Open, ClassifiedPosted Apr 23, 2026·Initiated Mar 18, 2026
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Reason: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Root cause: Labeling Change Control
Recalling firm: Diversatek HealthcareType: Dilator, EsophagealDistribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, BelgiumRecall #Z-1939-2026
Open, ClassifiedPosted Apr 23, 2026·Initiated Mar 18, 2026
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Reason: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Root cause: Labeling Change Control
Recalling firm: Diversatek HealthcareType: Dilator, EsophagealDistribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, BelgiumRecall #Z-1940-2026
Open, ClassifiedPosted Apr 23, 2026·Initiated Mar 18, 2026
Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Reason: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Root cause: Labeling Change Control
Recalling firm: Diversatek HealthcareType: Dilator, EsophagealDistribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, BelgiumRecall #Z-1941-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110.
May be included with the Olympus OER-ELITE.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1898-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1899-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1900-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1901-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1902-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Reason: XXX
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1903-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1904-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1905-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1906-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1907-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1908-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 25, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Reason: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Accessories, Cleaning, For EndoscopeDistribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.Recall #Z-1909-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2
UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
This device is intended for injection or aspiration of fluids. The needle protection device
covers the needle after use to help prevent needle sticks.
Reason: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
Root cause: Process control
Recalling firm: ARROW INTERNATIONAL, LLCType: Peripheral Catheter Insertion KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1910-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026
ARROW RADIAL ARTERY CATHETERIZATION KIT
REF ASK-04220-UCL1
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
REF ASK-04020-EUH2
UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869
REF ASK-04020-FMC
UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870
REF ASK-04020-MMC
UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880
The Arrow Arterial Catheterization Device permits access to the peripheral arterial
circulation or to other small vessels.
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Root cause: Process control
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter Guide Wire KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1911-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026
PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
The Arrow percutaneous sheath introducer permits venous access and catheter
introduction to the central circulation.
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Root cause: Process control
Recalling firm: ARROW INTERNATIONAL, LLCType: Percutaneous Sheath Introducer KitDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1912-2026
Open, ClassifiedPosted Apr 22, 2026·Initiated Mar 11, 2026
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM
UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409
The Arrow Epidural Catheter kit permits access to the epidural space for administration of
epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
The Arrow Combined Spinal Anesthesia and Epidural Catheterization products
permit access to subarachnoid and epidural spaces.
The Arrow Single Shot Epidural product permits access to the epidural space..
Reason: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Root cause: Process control
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Conduction, AnestheticDistribution: U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.Recall #Z-1913-2026