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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 661–680 of 1,000 recalls

Class IIOngoing

STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

Stryker Corporation

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

June 8, 2026 · DeviceView details →
Class IIOngoing

Optima XR200amx, Mobile Digital-Ready Radiographic System

GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

June 5, 2026 · DeviceView details →
Class IIOngoing

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

Olympus Corporation of the Americas

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

June 5, 2026 · DeviceView details →
Class IIOngoing

Optima XR220amx, Mobile Digital-Ready Radiographic System

GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

June 5, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

Medela Inc

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

June 5, 2026 · DeviceView details →
Class IIOngoing

Optima XR240amx, Mobile Digital Radiographic System

GE Medical Systems, LLC

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

June 5, 2026 · DeviceView details →
Class IIOngoing

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

Integra LifeSciences Corp. (NeuroSciences)

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

June 5, 2026 · DeviceView details →
Class IIOngoing

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

Philips North America Llc

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

June 5, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: The DisplayPort audio/video splitter is a 3rd party external accessory to Xhibit.

Spacelabs Healthcare, Inc.

Due to off-the-shelf display port component that has audio/video failures

June 4, 2026 · DeviceView details →
Class IIOngoing

VITEK 2 AST-N447 TEST KIT Product reference 424620

Biomerieux Inc

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

June 4, 2026 · DeviceView details →
Class IIOngoing

MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use

BD SWITZERLAND SARL

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

June 4, 2026 · DeviceView details →
Class IIOngoing

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Remel, Inc

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

June 3, 2026 · DeviceView details →
Class IIOngoing

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Penumbra, Inc.

Due to manufacturing issues, reperfusion catheters may fractures

June 3, 2026 · DeviceView details →
Class IIOngoing

The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.

Maquet Cardiovascular, LLC

Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.

June 2, 2026 · DeviceView details →
Class IIOngoing

Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Carl Zeiss Meditec AG

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

June 1, 2026 · DeviceView details →
Class IIOngoing

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed digitally via mobile application.

Emano Metrics, Inc.

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

May 29, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

May 28, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N

Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

May 28, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M

Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

May 28, 2026 · DeviceView details →
Class IIOngoing

Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407

Medline Industries, LP

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

May 28, 2026 · DeviceView details →
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