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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 841–860 of 1,000 recalls

Class IITerminated

Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.

Cardinal Health 200, LLC

The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.

May 21, 2021 · DeviceView details →
Class IITerminated

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

The Binding Site Group, Ltd.

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

May 20, 2021 · Device
View details →
Class IITerminated

SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

Smith & Nephew, Inc.

The device components experienced a manufacturing process error that resulted in surface damage from product handling.

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire

Bard Access Systems Inc.

Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

Caption Health

The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Misaligned placement of an axis mark can cause the patient to experience blurred vision

May 19, 2021 · DeviceView details →
Class IITerminated

5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

Bard Access Systems Inc.

Catheter kits contained the incorrect micro-introducers.

May 19, 2021 · DeviceView details →
Class IITerminated

Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962

Stryker Spine

The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

May 18, 2021 · DeviceView details →
Class IITerminated

The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.

Siemens Healthcare Diagnostics, Inc.

ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result

May 18, 2021 · DeviceView details →
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