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Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec Recalls

All product recalls associated with Linvatec Corp. dba ConMed Linvatec.

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Recall Summary

Total Recalls

1000

Past Year

566

Class I (Serious)

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 6301–6320 of 7756 recalls

Linvatec Corp. dba ConMed Linvatec: MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON...

Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONL...

Fire/Burn Risk

ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: Mpower PRO6200 Single Trigger Modular Handpiece, Mpower...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.

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FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Boston Scientific Corporation: Boston Scientific HydroThermAblator Endometrial Ablation ...

Fire/Burn Risk

Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.

FDAJul 31, 2009Nationwide• Boston Scientific Corporation

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Linvatec Corp. dba ConMed Linvatec: PRO5100, PowerPro Battery Modular Handpiece. Drill mode ...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Baxter Healthcare Corp.: Baxter's elastomeric infusion pumps are non-electronic, a...

Class IIModerate

FDAJul 31, 2009Nationwide• Baxter Healthcare Corp.

Linvatec Corp. dba ConMed Linvatec: Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo ...

ConMed has determined there is a possibility that the device may not fully retract once it is deployed.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number...

ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Linvatec Corp. dba ConMed Linvatec: PowerProMax PRO5100M Battery Single Trigger, PowerProMax...

There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

FDAJul 31, 2009Nationwide• Linvatec Corp. dba ConMed Linvatec

Beckman Coulter Inc.: Unicel DxH 800 Coulter Cellular Analysis System, Part num...

The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.

FDAJul 28, 2009Nationwide• Beckman Coulter Inc.

Spacelabs Healthcare, Incorporated: Spacelabs Medical Integrated ECG Cable are supplied as pa...

The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.

FDAJul 23, 2009Nationwide• Spacelabs Healthcare, Incorporated

Beckman Coulter Inc.: Tubing Assembly #142, V2, V12 Mixer/Wash a component of t...

The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. The impact of this issue would include: (1) Quality Control and patient results can potentially be affected. (2) If system has been calibrating properly and Quality Control is recovering within es

FDAJul 23, 2009Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-20...

The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica

FDAJul 20, 2009Nationwide• Beckman Coulter Inc.

Boston Scientific Corporation: Prolieve Thermodilatation Catheter Kit, a Transurethral M...

Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.

FDAJul 20, 2009Nationwide• Boston Scientific Corporation

Abbott Laboratories, Inc: ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer...

Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.

FDAJul 17, 2009Nationwide• Abbott Laboratories, Inc

Abbott Laboratories: CELL-DYN Emerald Hematology Analyzer, model number 09H39-...

Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.

FDAJul 16, 2009Nationwide• Abbott Laboratories

Bio-Rad Laboratories Inc: BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 ...

The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

FDAJul 14, 2009Nationwide• Bio-Rad Laboratories Inc

Toshiba American Medical Systems Inc: Whole Body X--ray Scanner This device is indicated as a ...

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

FDAJul 13, 2009Nationwide• Toshiba American Medical Systems Inc