CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Medline medical convenience kits labeled as: Shoulder Pack recalled

Medline Industries is recalling Medline medical convenience kits labeled as: Shoulder Pack, Medline Kit, distributed in 10 states. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.

Quantity recalled398 kits

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-2789-2026
FDA event ID: 99329
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jun 2026
FDA classified: 23 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Jun 2026	Recall initiated by company
23 Jul 2026	Classified by FDA	+42 days
29 Jul 2026	Published in enforcement report	+6 days

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

Reason for recall

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Product as listed by the FDA

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.

Where it was distributed

US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

Connecticut Florida Kansas Massachusetts Maryland Montana New York Ohio Oregon Virginia

Questions about this recall

Why was it recalled?

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

Which lots are affected?

Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25GBE239; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 24LBF187; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25ABM992; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25CBJ129; Medline Kit SKU DYNJ39590O, UDI/DI 10198459187780 (each) 40198459187781 (case), Lot Number 25DBI743; Medline Kit SKU DYNJ88566, UDI/DI 10198459179235 (each) 40198459179236 (case), Lot Number 24KBK487; Medline Kit SKU DYNJ911535, UDI/DI 10198459377600 (each) 40198459377601 (case), Lot Number 25FBU802.

Where was it sold?

US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.

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

3 other products · FDA event 99329

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	10 states
29 Jul 2026	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	10 states
29 Jul 2026	CLASS II	Medline medical convenience kits labeled as: Neuro Pack, Medline Kit recalled	Medline Industries	Other	10 states

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