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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1621–1640 of 39,430 recalls

Class IIOngoing

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Vivoo Protein Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

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)

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

S. Typhi/Para Typhi A Antigen

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

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

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Vivoo pH Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

LH One Step Ovulation Test Device (Urine)

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Menopause Test Cassette (Urine)

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Vivoo Vaginal pH Test

Changchun Wancheng Bio-Electron Co., Ltd.

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.

November 22, 2025 · DeviceView details →
Class IIOngoing

Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Medline Industries, LP

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

November 21, 2025 · DeviceView details →
Class IIOngoing

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Fresenius Kabi USA, LLC

Emphasizing instructions for LVP duration programming located in the IFU.

November 21, 2025 · DeviceView details →
Class IIOngoing

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

Roche Diagnostics Operations, Inc.

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

November 21, 2025 · DeviceView details →
Class IIOngoing

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00

CareFusion 303, Inc.

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

November 20, 2025 · DeviceView details →
Class IIOngoing

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG

Medtronic Neuromodulation

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

November 20, 2025 · DeviceView details →
Class IIOngoing

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Steris Corporation

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

November 19, 2025 · DeviceView details →
Class IIOngoing

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (such as bedpans, urinals, trays, bowl, basin and kidney dishes), rubber and plastic goods, theatre shoes and other similar and related articles found in healthcare facilities.

Steris Corporation

Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).

November 19, 2025 · DeviceView details →
Class IIOngoing

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Vortex Surgical Inc.

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

November 19, 2025 · DeviceView details →
Class IIIOngoing

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Instrumentation Laboratory

Recalled lots were manufactured with double the amount of preservative concentration.

November 18, 2025 · DeviceView details →
Class IIOngoing

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

Mindray DS USA, Inc. dba Mindray North America

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

November 18, 2025 · DeviceView details →
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