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Medtronic Heart Valves Division

Medtronic Heart Valves Division Recalls

All product recalls associated with Medtronic Heart Valves Division.

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Recall Summary

Total Recalls

398

Past Year

12

Class I (Serious)

56

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 81–100 of 398 recalls

Medtronic Heart Valves Division: CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut PRO PLUS Delivery Catheter System, REF: ...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDAJun 11, 2021AL, AK, AZ +45 more• Medtronic Heart Valves Division

Medtronic Heart Valves Division: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPR...

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

1...3 456 7...20

Page 5 of 20Next

Jun 11, 2021

AL, AK, AZ +45 more

• Medtronic Heart Valves Division

CooperVision Inc.: CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 ...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Dai...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Dispos...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposa...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Dispo...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily ...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 ...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

CooperVision Inc.: SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Dis...

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

FDAMay 19, 2021Nationwide• CooperVision Inc.

Stryker Medical Division of Stryker Corporation: Prime TC-transport chair intended for medical purposes t...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Proform- support surface is used to assist in the prevent...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Michael Graves with Stryker Highback Chair-intended for p...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Stretcher Chair-for use in all acute care hospitals and m...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: TruRize Clinical Chair - support structure that places hu...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: ComfortGel - assists in the prevention and treatment of a...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Electric MedSurg Bed FL23 - AC-powered adjustable hospita...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation

Stryker Medical Division of Stryker Corporation: Symmetry Plus Treatment Recliner - general hospital use a...

Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

FDAMay 12, 2021Nationwide• Stryker Medical Division of Stryker Corporation