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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 1–20 of 1,000 recalls

Class IIOngoing

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

June 16, 2026 · DeviceView details →
Class IIOngoing

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Accuray Incorporated

In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.

June 16, 2026 · Device
View details →
Class IIOngoing

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

CMR SURGICAL LIMITED

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

June 9, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

June 9, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

June 9, 2026 · DeviceView details →
Class IIOngoing

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

ConvaTec, Inc

Surgical dressing manufactured out of specification (greater thickness).

June 8, 2026 · DeviceView details →
Class IIOngoing

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Klowen Braces

A product error defect may cause incorrect bracket placement.

June 8, 2026 · DeviceView details →
Class IIOngoing

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Siemens Healthcare Diagnostics, Inc.

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.

June 8, 2026 · DeviceView details →
Class IIOngoing

ARTIS icono ceiling. Model Number: 11328100.

Siemens Medical Solutions USA, Inc

Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.

June 8, 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

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

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

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

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

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 →
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