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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 901–920 of 1,000 recalls

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 →
Class IITerminated

Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979

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

Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745

ADRIA SRL

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

May 17, 2021 · DeviceView details →
Class IITerminated

Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749

ADRIA SRL

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

May 17, 2021 · DeviceView details →
Class IITerminated

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

Cytocell Ltd.

The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

May 17, 2021 · DeviceView details →
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