CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report

Medline procedure packs containing Shenli syringes recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure packs containing Shenli syringes, labeled as follows: Dialysis Cath. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354

Quantity recalled1,679,067 units in total

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-2630-2024
FDA event ID: 94582
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 8 Apr 2024
FDA classified: 28 Aug 2024
Reported: 4 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Syringes & Needles

Timeline

8 Apr 2024	Recall initiated by company
28 Aug 2024	Classified by FDA	+142 days
4 Sep 2024	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

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Medline procedure packs containing Shenli syringes, labeled as follows: Dialysis Cath recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure packs containing Shenli syringes, labeled as follows: Dialysis Cath on 8 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2630-2024.

Why was it recalled?

Which lots are affected?

DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354

Where was it sold?

Worldwide distribution.

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 MEDLINE INDUSTRIES, LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	Bd Switzerland Sarl	Other	IL