RegWardenFDA facility compliance records
Company

THE ANSPACH EFFORT, INC.

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

Recalls by year

FDA actions on record by year2011: 6 recalls; 2012: 7 recalls; 2013: 4 recalls; 2014: 5 recalls; 2015: 5 recalls; 2016: 6 recalls; 2017: 1 recalls; 2022: 1 recalls6’117’124’135’145’156’161’17’18’19’20’211’22’23’24’25’26
  • Recalls (35)

Registered facilities (2)

Recalls & enforcement

20221 record
  • Class IIOngoing2022-12-07
    Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
20171 record
  • Class IITerminated2017-09-29
    This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
20166 records
  • Class IITerminated2016-10-06
    Supplied Directions for Use (DFU) did not contain a recommended service interval.
  • Class IITerminated2016-08-26
    The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
  • Class ITerminated2016-06-24
    There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
  • Class IITerminated2016-06-15
    The graphics at the attachment interface indicating locked and unlocked position are reversed.
  • Class IITerminated2016-03-28
    Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
  • Class IITerminated2016-01-15
    The device is reported to enter safe mode and is no longer able to charge batteries.
20155 records
  • Class IITerminated2015-11-25
    Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
  • Class IITerminated2015-11-02
    Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
  • Class IITerminated2015-07-01
    Saw head separated from the drive unit or began to come loose.
  • Class IITerminated2015-04-13
    G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
  • Class IITerminated2015-03-24
    The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.
20145 records
  • Class IITerminated2014-12-10
    Customer complaint indicating the color bands on the MIA16-G1 were not correct.
  • Class IIOngoing2014-11-14
    May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
  • Class IITerminated2014-08-14
    The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
  • Class IITerminated2014-05-08
    Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
  • Class IITerminated2014-01-08
    Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
20134 records
  • Class IITerminated2013-12-17
    Some carbide cutting burr fractured during use.
  • Class IITerminated2013-12-03
    The Irrigation Clips were assembled with the incorrect (smaller) clips.
  • Class IITerminated2013-05-06
    Product did not reach expected sterility assurance level
  • Class IITerminated2013-04-25
    The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air f…
20127 records
  • Class IITerminated2012-11-28
    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
  • Class IITerminated2012-10-26
    During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in …
  • Class IITerminated2012-09-05
    Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluat…
  • Class IITerminated2012-06-11
    Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
  • Class IITerminated2012-03-29
    The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use…
  • Class IITerminated2012-03-29
    Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
  • Class IITerminated2012-01-09
    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
20116 records
  • Class IITerminated2011-09-19
    Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
  • Class IITerminated2011-09-09
    Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.
  • Class IITerminated2011-06-24
    The RPM of the Motor Handpiece may be less than 80,000 RPM.
  • Class IITerminated2011-05-06
    Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim t…
  • Class IITerminated2011-03-31
    Cutter was longer than was stated on the label
  • Class IITerminated2011-03-04
    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “THE ANSPACH EFFORT, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1045834-the-anspach-effort-inc/

Not open yet

Alerts for THE ANSPACH EFFORT, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.