CLASS II ONGOING Device recall · Reported 7 Dec 2022 · FDA Enforcement Report

Busse Spine Injection Tray-Intended as a nerve block recalled

Busse Hospital Disposables is recalling Busse Spine Injection Tray-Intended as a nerve block, distributed in Texas. The recall was initiated on 21 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: (01) 00849233016705 Lot Number: 2230458

Quantity recalled40 cases

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-0326-2023
FDA event ID: 91079
Recalling firm: Busse Hospital Disposables, Hauppauge, NY
Classification: Class II
Status: Ongoing
Recall initiated: 21 Oct 2022
FDA classified: 29 Nov 2022
Reported: 7 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

21 Oct 2022	Recall initiated by company
29 Nov 2022	Classified by FDA	+39 days
7 Dec 2022	Published in enforcement report	+8 days

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

Reason for recall

Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable

Product as listed by the FDA

Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1

Where it was distributed

Texas

Questions about this recall

Is Busse Spine Injection Tray-Intended as a nerve block recalled?

Yes. Busse Hospital Disposables recalled Busse Spine Injection Tray-Intended as a nerve block on 21 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0326-2023.

Why was it recalled?

Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable

Which lots are affected?

UDI-DI: (01) 00849233016705 Lot Number: 2230458

Where was it sold?

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

More recalls from Busse Hospital Disposables

All 63

Reported	Class	Recall	Company	Reason	Where
10 Jan 2024Device	CLASS I	Catalog No. 800 Tracheostomy Care Tray - Sterile -Latex Free recalled	Busse Hospital Disposables	Sterility	Nationwide
10 Jan 2024Device	CLASS I	Catalog No. 1443 Dressing Change Tray / Sterile - Latex Free recalled	Busse Hospital Disposables	Sterility	Nationwide
10 Jan 2024Device	CLASS I	Catalog No. 9251R1, 9251R2, 9251R3 Tracheostomy Care SET / Sterile recalled	Busse Hospital Disposables	Sterility	Nationwide
7 Dec 2022Device	CLASS II	Busse Joint Injection Tray -Intended as a nerve block recalled	Busse Hospital Disposables	Other	TX
8 Jun 2022Device	CLASS II	Male SS Pellet Insertion Tray recalled by Busse Hospital Disposables	Busse Hospital Disposables	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide