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Stryker Instruments Div. Of Stryker Corporation FDA Record

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

4 Class I recalls
No warning letters matched by name

Inspections 0 0 OAI

Recalls 161

4 Class I (2%)

Warning letters 0 None on file

510(k) clearances 0 None on file

Stryker Instruments Div. Of Stryker Corporation has 161 FDA recalls (4 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stryker Instruments Div. Of Stryker Corporation" is on file.

What these totals cover: FDA records filed under the name "Stryker Instruments Div. Of Stryker Corporation".

Latest recall: Z-1452-2022 · Class II · Jun 15, 2022

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	161 (4 Class I)	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	0	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Stryker Instruments Div. Of Stryker Corporation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Stryker Instruments Div. Of Stryker Corporation: FDA recall records per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	1	0
2021	0	0	0	0	0
2020	0	0	0	6	0
2019	0	0	0	5	0
2018	0	0	0	12	0
2017	0	0	0	16	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 recalls

161 recall records from May 24, 2011 to Jun 15, 2022. Showing the 20 most recent. View all 161 recall records

Number	Class	Product	Date
Z-1452-2022	Class II	SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for…	Jun 15, 2022
Z-0431-2021	Class II	Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting…	Oct 16, 2020
Z-1807-2020	Class II	Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP…	Mar 26, 2020
Z-1402-2022	Class II	Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L…	Jan 22, 2020
Z-1098-2020	Class II	Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that…	Jan 13, 2020
Z-1097-2020	Class II	SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil…	Jan 13, 2020
Z-1099-2020	Class II	Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75…	Jan 13, 2020
Z-0592-2020	Class II	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port)…	Nov 6, 2019
Z-0593-2020	Class II	Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port)…	Nov 6, 2019
Z-0023-2020	Class II	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve…	Jul 31, 2019
Z-0024-2020	Class II	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve…	Jul 31, 2019
Z-1215-2019	Class II	Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy…	Mar 19, 2019
Z-1394-2022	Class III	Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6	Dec 4, 2018
Z-1503-2018	Class II	T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment	Feb 23, 2018
Z-1500-2018	Class II	T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment	Feb 23, 2018
Z-1505-2018	Class II	T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment	Feb 23, 2018
Z-1502-2018	Class II	T4 Pullover Toga, Regular ; Catalog Number: 0400-750-000 Sterile personal protection garment	Feb 23, 2018
Z-1506-2018	Class II	T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment	Feb 23, 2018
Z-1507-2018	Class II	T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal…	Feb 23, 2018
Z-1510-2018	Class II	T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal…	Feb 23, 2018

Stryker Instruments Div. Of Stryker Corporation and the FDA: common questions

Has Stryker Instruments Div. Of Stryker Corporation received an FDA warning letter?

No FDA warning letter addressed to the name "Stryker Instruments Div. Of Stryker Corporation" 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 Stryker Instruments Div. Of Stryker Corporation received an FDA Form 483?

FDA has not published a Form 483 for "Stryker Instruments Div. Of Stryker Corporation" in its reading room. FDA publishes some Form 483s, not all of them.

Has Stryker Instruments Div. Of Stryker Corporation had an FDA recall?

Yes. Stryker Instruments Div. Of Stryker Corporation has 161 FDA recalls on record, 4 of them Class I, the most serious class. The most recent started Jun 15, 2022.

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