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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 3141–3160 of 39,430 recalls

Class IIIOngoing

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Bausch & Lomb Surgical, Inc.

An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.

June 6, 2025 · DeviceView details →
Class IIOngoing

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

Waismed Ltd.

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

June 5, 2025 · Device
View details →
Class IIOngoing

Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

Waismed Ltd.

Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.

June 5, 2025 · DeviceView details →
Class IIOngoing

Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

Merit Medical Systems, Inc.

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

June 5, 2025 · DeviceView details →
Class IIOngoing

Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

Merit Medical Systems, Inc.

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

June 5, 2025 · DeviceView details →
Class IIOngoing

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

Merit Medical Systems, Inc.

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

June 5, 2025 · DeviceView details →
Class IIOngoing

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

Merit Medical Systems, Inc.

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

June 5, 2025 · DeviceView details →
Class IIIOngoing

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Diversatek Healthcare

Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

June 4, 2025 · DeviceView details →
Class IIOngoing

UROSKOP Omnia Max. Model Number: 10762473

Siemens Medical Solutions USA, Inc

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

June 4, 2025 · DeviceView details →
Class IIOngoing

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

Siemens Healthcare Diagnostics, Inc.

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

June 4, 2025 · DeviceView details →
Class IIOngoing

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

Siemens Healthcare Diagnostics, Inc.

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

June 4, 2025 · DeviceView details →
Class IIOngoing

Azurion 7 M20. Fluoroscopic X-Ray System.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.

June 4, 2025 · DeviceView details →
Class IIIOngoing

Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

DRG International, Inc.

An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).

June 4, 2025 · DeviceView details →
Class IIOngoing

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Siemens Healthcare Diagnostics, Inc.

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

June 4, 2025 · DeviceView details →
Class IIOngoing

UROSKOP Omnia. Model Number: 10094910

Siemens Medical Solutions USA, Inc

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

June 4, 2025 · DeviceView details →
Class IIOngoing

ADVIA¿ 120/2120/2120i SETpoint Calibrator

Siemens Healthcare Diagnostics, Inc.

Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

June 4, 2025 · DeviceView details →
Class IIOngoing

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.

Becton, Dickinson and Company, BD Bio Sciences

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

June 3, 2025 · DeviceView details →
Class IIOngoing

SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

ICU Medical, Inc.

Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.

June 3, 2025 · DeviceView details →
Class IIOngoing

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

C.R. Bard Inc

Cather packaging may contain the incorrect French size.

June 3, 2025 · DeviceView details →
Class IOngoing

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

Given Imaging Ltd.

It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.

June 3, 2025 · DeviceView details →
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