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LeMaitre Vascular, Inc.

LeMaitre Vascular, Inc. Recalls

All product recalls associated with LeMaitre Vascular, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

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 5741–5760 of 37665 recalls

Chevalier Valvulotome (LeMaitre) – Cutter Surface Defect (2023)

Laceration Risk

Burrs (molding flash) on the cutter may tear the harvested vien

Moderate

FDAJul 13, 2023Nationwide• LeMaitre Vascular, Inc.

Methylphenidate Tablets (Sun Pharmaceutical) – foreign substance (2023)

Presence of Foreign Substance: Metal embedded in a tablet.

Class IIModerate

FDAJul 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class II

1...286 287288289 290...1884

Page 288 of 1884Next

Moderate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

IMPIX 3D (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX MANTA (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

PASS LP (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

2021 ENTEGRA ACCOLADE – jayco, inc (2023)

Jayco, Inc. (Jayco) is recalling certain 2021-2022 Entegra Coach Accolade, Accolade XL, Jayco Seneca, and Seneca Prestige recreational vehicles. The windshield wipers may fail, resulting in reduced driver visibility.

High

NHTSAJul 12, 2023Nationwide• ENTEGRA

Air/Water Valve (Olympus) – Valve Functionality Loss (2023)

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

High

FDAJul 12, 2023Nationwide• Olympus Corporation of the Americas

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753,... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

Incorrect Laser Marking - Solera Awl Tip Tap

Low

FDAJul 12, 2023Nationwide• Medtronic Sofamor Danek USA, Inc

GRANVIA-C (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX TLIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

Moderate

FDAJul 12, 2023Nationwide• Abbott Diabetes Care, Inc.

IMPIX ALIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX ALIF S/A (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX DLIF (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX C+ (Medicrea) – Packaging Pinhole Issue (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

Lipemic interference failed to meet the performance specification listed within the IFU.

Moderate

FDAJul 12, 2023AL, AZ, AR +40 more• Beckman Coulter Inc.

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

High

FDAJul 11, 2023Nationwide• Boston Scientific Corporation