RegWardenFDA facility compliance records
Facility

Consolidated Medical Equipment Company

24 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 3 recalls; 2014: 3 recalls; 2015: 3 recalls; 2016: 3 recalls; 2017: 3 recalls; 2018: 1 recalls; 2019: 1 recalls; 2020: 1 recalls; 2021: 1 recalls; 2022: 1 recalls; 2026: 2 recalls2’123’133’143’153’163’171’181’191’201’211’22’23’24’252’26
  • Recalls (24)

Devices registered here (1)

  • Apparatus, Exhaust, Surgical
    Product code FYD (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.5070

Recalls & enforcement

20262 records
20221 record
  • Class IITerminated2022-11-18
    Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.
20211 record
  • Class IITerminated2021-03-26
    Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
20201 record
  • Class IITerminated2020-11-12
    Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
20191 record
20181 record
  • Class IITerminated2018-02-23
    Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
20173 records
  • Class IITerminated2017-06-19
    Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
  • Class IITerminated2017-04-17
    Manufactured with the incorrect anchor outer body
  • Class IITerminated2017-02-28
    For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were S…
20163 records
  • Class IITerminated2016-08-29
    CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.
  • Class IITerminated2016-06-27
    The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
  • Class IITerminated2016-05-18
    A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
20153 records
  • Class IITerminated2015-12-21
    Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
  • Class IITerminated2015-11-05
    Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.
  • Class IITerminated2015-06-17
    Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
20143 records
  • Class ITerminated2014-11-06
    Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
  • Class IITerminated2014-05-08
    ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
  • Class IITerminated2014-02-20
    ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
20133 records
  • Class IITerminated2013-10-23
    The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exp…
  • Class IITerminated2013-05-03
    ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the pati…
  • Class IITerminated2013-01-28
    Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
20122 records
  • Class IITerminated2012-12-27
    ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier ha…
  • Class IITerminated2012-11-20
    ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it mus…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Consolidated Medical Equipment Company (FEI 3007305485) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007305485-consolidated-medical-equipment-company/

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