Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2070-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2071-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2072-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2073-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2074-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2075-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2076-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2077-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2078-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2079-2026
Open, ClassifiedPosted May 6, 2026·Initiated Mar 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Reason: Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
Root cause: Under Investigation by firm
Recalling firm: Katalyst Surgical, LLCType: Forceps, OphthalmicDistribution: Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.Recall #Z-2080-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 1, 2026
Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485
Reason: Respiratory/sore throat panel test may result in false negative results and control failures.
Root cause: Under Investigation by firm
Recalling firm: BioFire Diagnostics, LLCType: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsDistribution: US Nationwide distribution in the states of MS, TX MN, VA.Recall #Z-2081-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
One Step 10A in vitro diagnostic test
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Kit, Test, Multiple, Drugs Of Abuse, Over The CounterDistribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2082-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
One Step UTI in vitro diagnostic test
REF: 3374
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Test, Urine LeukocyteDistribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2083-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
One Step pH in vitro diagnostic test
REF: 31I4P
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Dye-Indicator, Ph (Urinary, Non-Quantitative)Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2084-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
QUCARE Total Cholesterol in vitro diagnostic test
REF: 6407
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Enzymatic Esterase--Oxidase, CholesterolDistribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2085-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
Uric Acid in vitro diagnostic test
REF: 31H0P
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Acid, Uric, Uricase (Colorimetric)Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2086-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
One Step K in vitro diagnostic test
REF: 81A4
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Nitroprusside, Ketones (Urinary, Non-Quant.)Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2087-2026
Open, ClassifiedPosted May 6, 2026·Initiated Apr 2, 2026
One Step P in vitro diagnostic test
REF: 8194
Reason: The devices were distributed without required FDA premarket clearance or approval.
Root cause: No Marketing Application
Recalling firm: DFI Co., Ltd.Type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.Recall #Z-2088-2026
Open, ClassifiedPosted May 4, 2026·Initiated Apr 13, 2026
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045;
LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096;
LIFEPAK 35, REF: 99335-000013, 99335-000031;
LIFEPAK 20e, REF: 99507-000122
Reason: Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Root cause: Process control
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: US Nationwide distribution in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, WI.Recall #Z-2065-2026