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Henke Sass Wolf Of America, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Sep 16, 2025
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 9 Latest Mar 18, 2008

Henke Sass Wolf Of America, Inc. has 0 FDA recalls, 3 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Henke Sass Wolf Of America, Inc." is on file.

What these totals cover: FDA records filed under the name "Henke Sass Wolf Of America, Inc." and its spelling variant "Henke Sass Wolf Of America".

Latest inspection: Sep 16, 2025 · VAI
Latest 510(k): Mar 18, 2008

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	9	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Henke Sass Wolf Of America, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Henke Sass Wolf Of America, Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

3 inspections from Mar 25, 2019 to Sep 16, 2025.

Date	Site	Product	Classification	FEI
Sep 16, 2025	Dudley, MA	Devices	Voluntary Action Indicated (VAI)	1000120548
Aug 11, 2021	Dudley, MA	Devices	Voluntary Action Indicated (VAI)	1000120548
Mar 25, 2019	Dudley, MA	Devices	Voluntary Action Indicated (VAI)	1000120548

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000120548	Dudley, MA	3	Sep 16, 2025

Recent 510(k) clearances

9 510(k) clearances from May 16, 1994 to Mar 18, 2008.

K-Number	Device	Date
K080560	HENKE SASS WOLF OF AMERICA ARTHROSCOPE	Mar 18, 2008
K050163	HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE	Mar 24, 2005
K030572	HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE	Apr 1, 2003
K013611	HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE	Feb 1, 2002
K991563	CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE…	Oct 13, 1999
K983067	FINE-JECT	Oct 30, 1998
K981751	SINUSCOPE AND ACCESSORIES	Aug 13, 1998
K962075	HSW GMBH ARTHROSCOPE	Jan 17, 1997
K941541	HSV LAPAROSCOPY SET	May 16, 1994

Henke Sass Wolf Of America, Inc. and the FDA: common questions

Has Henke Sass Wolf Of America, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Henke Sass Wolf Of America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Henke Sass Wolf Of America, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Henke Sass Wolf Of America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Henke Sass Wolf Of America, Inc.?

The most recent FDA inspection on file ended Sep 16, 2025 at Dudley, MA and was classified VAI. FDA has 3 inspections of Henke Sass Wolf Of America, Inc. on file.

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