Open, ClassifiedPosted May 15, 2026·Initiated Mar 23, 2026
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers:
(1) TNG4002-IND.
(2) TNG-4007-6pk.
Reason: Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Root cause: Process control
Recalling firm: TANGENT ENDOSCOPY, LLCType: Choledochoscope And Accessories, Flexible/RigidDistribution: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.Recall #Z-2209-2026
Open, ClassifiedPosted May 14, 2026·Initiated Apr 6, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
Reason: Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Root cause: Mixed-up of materials/components
Recalling firm: MICROVENTION INC.Type: Intracranial Coil-Assist StentDistribution: International distribution to the country of China.Recall #Z-2200-2026
Open, ClassifiedPosted May 14, 2026·Initiated Apr 8, 2026
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices:
1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A;
2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B;
3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C;
4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D;
5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E;
6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Reason: Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Root cause: Under Investigation by firm
Recalling firm: Medtronic NeuromodulationType: Pump, Infusion, Implanted, ProgrammableDistribution: Worldwide distribution.Recall #Z-2201-2026
Open, ClassifiedPosted May 13, 2026·Initiated Mar 25, 2026
Rolls of label stock used with the Omnicell i.v.Station.
1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM).
2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM).
Model/Catalog Number: IVS-RBT-001.
i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.
Reason: Potential for mislabeled syringe produced by the i.v.STATION device.
Root cause: Process control
Recalling firm: Omnicell, Inc.Type: System/Device, Pharmacy CompoundingDistribution: US Distribution in Alabama, Maryland and Pennsylvania.Recall #Z-2047-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Reason: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Hemodialysis, ImplantedDistribution: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZWRecall #Z-2156-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE;
Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM;
Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE;
Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM
Reason: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Hemodialysis, ImplantedDistribution: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZWRecall #Z-2157-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP;
Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM
Reason: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Hemodialysis, ImplantedDistribution: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZWRecall #Z-2158-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX;
NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM;
NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X;
NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
Reason: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Root cause: Nonconforming Material/Component
Recalling firm: ARROW INTERNATIONAL, LLCType: Catheter, Hemodialysis, ImplantedDistribution: Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZWRecall #Z-2159-2026
Open, ClassifiedPosted May 13, 2026·Initiated Mar 27, 2026
Edwards EVOQUE tricuspid delivery system
REF:9850TDS
Sterile EO
Reason: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Root cause: Labeling design
Recalling firm: Edwards Lifesciences, LLCType: Percutaneously Delivered Prostheses And Tricuspid ValvesDistribution: Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.Recall #Z-2172-2026 Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501.
The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.
Root cause: Process control
Recalling firm: Integra LifeSciences Corp. (NeuroSciences)Type: Shunt, Central Nervous System And ComponentsDistribution: US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).Recall #Z-2173-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2174-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2175-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2176-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2177-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2178-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2179-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2180-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2181-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2182-2026
Open, ClassifiedPosted May 13, 2026·Initiated Apr 10, 2026
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason: Incomplete seals on sterile product
Root cause: Process control
Recalling firm: Stryker Sustainability SolutionsType: Catheter, Recording, Electrode, ReprocessedDistribution: US Nationwide and the countries of Israel and Canada.Recall #Z-2183-2026