Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1250-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Tecfen Retractable Membrane Polisher, QTPR1267-23
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Hook, OphthalmicDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1251-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Vortex Surgical I2 Injection Kit, VS0500
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Kit, Surgical Instrument, DisposableDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1252-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Hook, OphthalmicDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1253-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Reason: XXX
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Transilluminator, Ac-PoweredDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1254-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Vortex Surgical
25GA Backflush, VS0270.25;
25GA Backflush Retractable, VS0275.27
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl AcetalDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1255-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Dec 16, 2025
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Root cause: Employee error
Recalling firm: Vortex Surgical Inc.Type: Marker, ScleraDistribution: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.Recall #Z-1256-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
LotFancy Urinary Tract Infection Urine (UTI) Test Strips;
PALINOIA UTI-10 PARAMETER REAGENT STRIPS;
Vaunn Medical 8-in-1 Urinalysis Reagent Strip;
JNW Direct 4-in-1 UTl Urinalysis Test Strips;
Urinify STRENGTH;
Urinify ESSENTIAL,
Urinify Urinary Tract Infection (UTI)
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Test, Urine LeukocyteDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1257-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips;
URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein;
Vivoo Ketone Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Nitroprusside, Ketones (Urinary, Non-Quant.)Distribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1258-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
LH One Step Ovulation Test Device (Urine)
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Test, Luteinizing Hormone (Lh), Over The CounterDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1259-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Menopause Test Cassette (Urine)
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Test, Follicle Stimulating Hormone (Fsh), Over The CounterDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1260-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
S. Typhi/Para Typhi A Antigen
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Antiserum, Typhus FeverDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1261-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Male Fertility Sperm Test for Home Use (Cassette)
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Material, Quality Control, Semen AnalysisDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1262-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Sperm, Antigen, Antiserum, ControlDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1263-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Vivoo pH Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Dye-Indicator, Ph (Urinary, Non-Quantitative)Distribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1264-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Vivoo Protein Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)Distribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1265-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Vivoo Vaginal pH Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Paper, Obstetric PhDistribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1266-2026
Open, ClassifiedPosted Feb 4, 2026·Initiated Nov 22, 2025
Vivoo Sodium Test;
Vivoo Vitamin C Test;
Vivoo Hydration Test
Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Root cause: No Marketing Application
Recalling firm: Changchun Wancheng Bio-Electron Co., Ltd.Type: Urinalysis Controls (Assayed And Unassayed)Distribution: US Nationwide distribution in the states of TX, GA, CA.Recall #Z-1267-2026
Open, ClassifiedPosted Feb 3, 2026·Initiated Dec 19, 2025
SOMATOM X.ceed
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Root cause: Under Investigation by firm
Recalling firm: Siemens Medical Solutions USA, IncType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.Recall #Z-1239-2026
Open, ClassifiedPosted Feb 3, 2026·Initiated Dec 19, 2025
NAEOTOM Alpha
Software applications:
syngo.CT Brain Quantification
syngo.CT Vessel Hyperdensities
syngo.CT ASPECTS
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Root cause: Under Investigation by firm
Recalling firm: Siemens Medical Solutions USA, IncType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.Recall #Z-1240-2026