CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

6376 M-1 Cot Fastener recalled by Stryker Medical Division of

Stryker Medical Division of Stryker is recalling 6376 M-1 Cot Fastener. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358

Quantity recalled59

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1598-2018
FDA event ID: 79817
Recalling firm: Stryker Medical Division of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2018
FDA classified: 2 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Mar 2018	Recall initiated by company
2 May 2018	Classified by FDA	+54 days
9 May 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Product as listed by the FDA

6376 M-1 Cot Fastener, catalog no. 6376000000

Where it was distributed

Product distributed to the Netherlands

Questions about this recall

Why was it recalled?

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Which lots are affected?

Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358

Where was it sold?

Product distributed to the Netherlands

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 79817

This product is part of a recall event; the main page for the event is 6381 M-1 Cot Fastener recalled by Stryker Medical Division of.

Reported	Class	Recall	Company	Reason	Where
9 May 2018	CLASS II	6381 M-1 Cot Fastener recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	MI

More recalls from Stryker Medical Division of Stryker

All 69

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Device	CLASS II	Cub Pediatric Crib recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
17 Dec 2025Device	CLASS II	Stryker MV3 bariatric bed recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
17 Dec 2025Device	CLASS II	Stryker Arise 1000EX mattress recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
13 Dec 2023Device	CLASS II	ProCuity bed series recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide
13 Dec 2023Device	CLASS II	ProCuity bed series recalled by Stryker Medical Division of	Stryker Medical Division of Stryker	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide