thejoe The Anspach Effort, Inc.

The Anspach Effort, Inc.: 261 FDA recall reports

Every medical device recall the FDA has published for The Anspach Effort, Inc.. The fault, and how the agency graded it.

261Reports

2Class I

10Ongoing

2023-01-18Most recent

2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	259
Class I	2

By year reported

Year	Reports
2012	4
2013	8
2014	85
2015	37
2016	14
2017	103
2018	1
2023	9

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Pediatric Craniotome Ref:CRANI-P-G1

Z-0924-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: Pediatric Craniotome Ref:CRANI-P-G1
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cra

Z-0921-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R

Z-0922-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intende

Z-0923-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended f

Z-0920-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R

Z-0919-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRAN

Z-0917-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A I

Z-0916-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

Z-0918-2023 · Class II · reported 2023-01-18 · Ongoing

Why it was recalled: 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
Product: Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Where it went: US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
How much: 6059 units in total

OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use duri

Z-0398-2018 · Class II · reported 2018-01-31 · Terminated

Why it was recalled: This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
Product: OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
Where it went: Internationally to Canada
How much: 1

Keyless Driver Product Usage: Pneumatic system

Z-1995-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Keyless Driver Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 121

14cm QD Angle Attachment Product Usage: Pneumatic system

Z-2022-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 14cm QD Angle Attachment Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 238

Electric Handpiece EM Hand Control Product Usage: Electric system

Z-1947-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Electric Handpiece EM Hand Control Product Usage: Electric system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 32

6.8cm Controlled Depth Attachment Product Usage: Pneumatic system

Z-1985-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 4

SMALL ATTACHMENT, J-LATCH

Z-2028-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: SMALL ATTACHMENT, J-LATCH
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 16

IMRI AIR CONTROL Product Usage: Pneumatic system

Z-1942-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: IMRI AIR CONTROL Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 3

14cm QD Angle Attachment Product Usage: Product attachment

Z-1930-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 14cm QD Angle Attachment Product Usage: Product attachment
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

XMAX Motor, High Strength Hose Product Usage: Pneumatic system

Z-1945-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: XMAX Motor, High Strength Hose Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 22

12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

Z-1981-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 297

Rotating Adult Craniotome Product Usage: Pneumatic system

Z-1988-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Rotating Adult Craniotome Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 49

Foot Control without Switches, SC2100 Product Usage: Electric system

Z-1954-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Foot Control without Switches, SC2100 Product Usage: Electric system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 22

STANDARD CRANIOTOME, BLACK MAX

Z-1962-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: STANDARD CRANIOTOME, BLACK MAX
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 148

11cm QD Angle Attachment Product Usage: Pneumatic system

Z-2020-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 11cm QD Angle Attachment Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 455

System Console, Single Port, with irrigation Product Usage: Electric system

Z-1956-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: System Console, Single Port, with irrigation Product Usage: Electric system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 462

Rotating Large Craniotome

Z-1990-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Rotating Large Craniotome
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 8

BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system

Z-1941-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 25

Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system

Z-2006-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 568

IMRI SHORT ATTACHMENT Product Usage: Pneumatic system

Z-1997-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 14

90 degree Contra Angle Attachment Product Usage: Pneumatic system

Z-2018-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: 90 degree Contra Angle Attachment Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Foot control irrigation system Product Usage: Pneumatic system

Z-1933-2017 · Class II · reported 2017-05-10 · Terminated

Why it was recalled: Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product: Foot control irrigation system Product Usage: Pneumatic system
Where it went: Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
How much: 1

Showing the 30 most recent of 261. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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