Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Pet Allergy Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0813-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Pollen Allergy Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0814-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Serotonin Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/SerotoninDistribution: US Nationwide distribution.Recall #Z-0815-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
2 in 1 Trichomonas / Gardnerella Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Trichomonas Vaginalis Nucleic Acid Amplification Test SystemDistribution: US Nationwide distribution.Recall #Z-0816-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
3 in 1 STI Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Trichomonas Vaginalis Nucleic Acid Amplification Test SystemDistribution: US Nationwide distribution.Recall #Z-0817-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
8 in 1 STI Test Kit
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Trichomonas Vaginalis Nucleic Acid Amplification Test SystemDistribution: US Nationwide distribution.Recall #Z-0818-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Oct 28, 2025
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Reason: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Blood Pressure CuffDistribution: US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.Recall #Z-0847-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Root cause: Labeling design
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.Recall #Z-0848-2026
Open, ClassifiedPosted Nov 28, 2025·Initiated Sep 17, 2025
InSure ONE Fecal Immunochemical Test. Labeled as follows:
1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.
2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025.
3. InSure ONE POL Combo Pack. Model Number: 90030.
InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Root cause: Under Investigation by firm
Recalling firm: Enterix, Inc.Type: Reagent, Occult BloodDistribution: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.Recall #Z-0725-2026
Open, ClassifiedPosted Nov 28, 2025·Initiated Oct 29, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Reason: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Root cause: Software design
Recalling firm: Medtronic, Inc.Type: Implantable Cardioverter Defibrillator (Non-Crt)Distribution: Worldwide - US Nationwide distribution.Recall #Z-0726-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 30, 2025
FlexLab (FLX);
Version: FLX-217-10;
Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of
mALX to perform error recoveries or maintenance procedures and do not empty the printer
tubes buffer to remove all the secondary sample tubes.
Root cause: Device Design
Recalling firm: Inpeco S.A.Type: Electrode, Ion Specific, PotassiumDistribution: US Domestic: MI.
OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.Recall #Z-0595-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 30, 2025
FlexLab (FLX);
Version: FLX-217-40;
Reason: The Aliquoter Module (mALX) may
generate secondary sample tubes without labels or with mismatched labels which may result in
delayed results or erroneous results, this error occurs if the operators open the printer head of
mALX to perform error recoveries or maintenance procedures and do not empty the printer
tubes buffer to remove all the secondary sample tubes
Root cause: Device Design
Recalling firm: Inpeco S.A.Type: Electrode, Ion Specific, PotassiumDistribution: US Domestic: MI.
OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.Recall #Z-0596-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Sep 12, 2025
Brand Name: Galaxy System
Product Name: Galaxy System
Model/Catalog Number: GAL-001
Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and
access to patient airways for diagnostic and therapeutic procedure.
Reason: Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
Root cause: Under Investigation by firm
Recalling firm: Noah Medical CorporationType: Bronchoscope (Flexible Or Rigid)Distribution: US distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN, PA, MD, VA, WI, CO, SC, IL, NC and OUS (Foreign) to countries of: Hong Kong and AustraliaRecall #Z-0598-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 31, 2025
NICO Myriad Handpiece
Product Number/Product Name:
NN-8000
15x10 MHP;
NN-8001
15x 13 MHP;
NN-8002
15x 25 MHP - MINOP;
NN-8003
13x10 MHP;
NN-8004
13x13 MHP;
NN-8005
15x25 MHP GAAB;
NN-8006
11X10 MHP;
NN-8007
11x13 MHP;
NN-8008
19x28 MHP OI;
NN-8010
17x31.5 MHP DECQ;
NN-8015
NICO Fluid System (NFS);
NN-8017
11x13 MHP/PB;
NN-8018
13X13 MHP/PB;
NN-8019
19x28 MHP Little LOTTA;
NN-8020
19x21.5 MHP PaediScope;
NN-8021
15x26.5 MHP LOTTA;
NN-8500
15x10 MHP;
NN-8501
15x13 MHP;
NN-8502
15x25 MINOP MHP;
NN-8503
13x10 MHP;
NN-8504
13x13 MHP;
NN-8505
15x25 GAAB MHP;
NN-8506
11X10 MHP;
NN-8507
11x13 MHP;
NN-8508
19x28 OI MHP;
NN-8510
17x31.5 DECQ MHP;
NN-8517
13X13 MHP/PB;
NN-8518
11x13 MHP/PB;
NN-8519
19x28 Little LOTTA MHP;
NN-8520
19x21.5 PaediScope MHP;
NN-8521
15X26.5 LOTTA MHP;
Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.Recall #Z-0599-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 31, 2025
NICO Myriad Illumination Pack
Product No. NN-1000
11g Illumination Sleeve/Fiber;
Product No. NN-1001
13g Illumination Sleeve/Fiber
Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.Recall #Z-0600-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 31, 2025
NICO BrainPath;
Product Number/Product Name
NN-8024
BrainPath Shephard's Hook - Greenberg;
NN-8025
BrainPath Shephard's Hook - Sugita;
NN-8026
BrainPath Shephard's Hook - Budde;
NN-8042
BrainPath Shephard's Hook - Greenberg LK;
Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.Recall #Z-0601-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 22, 2025
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of 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:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC
OUS: NoneRecall #Z-0602-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers:
1. Primary Gravity IV Set, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443.
2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447.
3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448.
4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0603-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0604-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0605-2026