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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 1,000 recalls

Class IIOngoing

One Step K in vitro diagnostic test REF: 81A4

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

Uric Acid in vitro diagnostic test REF: 31H0P

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Ongoing

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

One Step P in vitro diagnostic test REF: 8194

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

One Step pH in vitro diagnostic test REF: 31I4P

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

Intuitive Surgical, Inc.

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

April 2, 2026 · DeviceView details →

Class IIOngoing

One Step 10A in vitro diagnostic test

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

April 2, 2026 · DeviceView details →

Class IIOngoing

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

Siemens Healthcare Diagnostics Inc

Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

April 2, 2026 · DeviceView details →

Class IIOngoing

Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY

Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

April 2, 2026 · DeviceView details →

Class IIOngoing

One Step UTI in vitro diagnostic test REF: 3374

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →

Class IIOngoing

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Merit Medical Systems, Inc.

catheter may experience resistance when being advanced over the guidewire

April 2, 2026 · DeviceView details →

Class IIOngoing

i-STAT G3+ cartridge; List Number: 03P78-26;

Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

April 1, 2026 · DeviceView details →

Class IIOngoing

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Aniara Diagnostica LLC

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

April 1, 2026 · DeviceView details →

Class IIOngoing

i-STAT EG7+ cartridge; List Number: 03P76-25;

Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

April 1, 2026 · DeviceView details →

Class IIOngoing

i-STAT EG6+ cartridge; List Number: 03P77-25;

Abbott Point Of Care Inc.

Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

April 1, 2026 · DeviceView details →

Class IIOngoing

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

BioFire Diagnostics, LLC

Respiratory/sore throat panel test may result in false negative results and control failures.

April 1, 2026 · DeviceView details →

Class IIOngoing

ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208

Erbe Medical, LLC

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

March 31, 2026 · DeviceView details →

Class IIOngoing

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.

March 31, 2026 · DeviceView details →

Class IIOngoing

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

Erbe Medical, LLC

Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

March 31, 2026 · DeviceView details →

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