CLASS II ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report

Sterile Procedural Trays, labeled as the following recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Sterile Procedural Trays, labeled as the following: a, distributed nationwide in the US. The recall was initiated on 17 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;

Quantity recalled174 cases (750 units)

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-1070-2023
FDA event ID: 91386
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 17 Nov 2022
FDA classified: 6 Feb 2023
Reported: 15 Feb 2023
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Dental Devices

Timeline

17 Nov 2022	Recall initiated by company
6 Feb 2023	Classified by FDA	+81 days
15 Feb 2023	Published in enforcement report	+9 days

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

Reason for recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Nationwide

Questions about this recall

Is Sterile Procedural Trays, labeled as the following: a recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Sterile Procedural Trays, labeled as the following: a on 17 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-1070-2023.

Why was it recalled?

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Which lots are affected?

a. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

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.

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