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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Medical Convenience Kits Recalled Due to Faulty Plastic Syringes

Agency Publication Date: August 28, 2024
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Summary

Medline Industries, LP is recalling various medical convenience kits that contain plastic syringes produced by a third party. These syringes are subject to a previous FDA Safety Alert due to reports of leaks, breakage, and other quality issues that can lead to incorrect dosing or device failure. The recall impacts a wide range of specialized medical sets, including anesthesia circuits, baby care kits, heart surgery packs, and circumcision trays, which were distributed worldwide.

Risk

The plastic syringes in these kits may leak or break during use, which can lead to life-threatening issues such as improper medication delivery, air entering the bloodstream, or procedural delays. No specific injuries were noted in this alert, but the defect poses a medium risk to patient health depending on the medical procedure being performed.

What You Should Do

  1. Identify if you have any affected Medline procedural kits by checking the Pack Number and Lot Number on the outer packaging labels.
  2. Check for specific anesthesia kits like ANESTHESIA CIRCUIT PEDS-LF (Pack DYNJAA0327F, Lot 20LBV329) or baby care kits such as BABY CARE KIT UNIV (Pack DYKL1025, Lot 21JBA955).
  3. Verify surgical trays such as OPEN HEART PEDS (Pack CDS981050Q, Lot 23IBJ172) or CIRCUMCISION TRAY (Pack CIT6715, Lot 2023050590) against the extensive list of recalled codes.
  4. Immediately stop using any kits that match the recalled Pack Numbers and Lot Numbers identified in the product list.
  5. Contact your healthcare provider or Medline Industries, LP at 1-800-MEDLINE for specific instructions on how to return or replace the affected components and to discuss potential impact on patient care.
  6. For additional information, you may contact the FDA at 1-888-463-6332 or visit the FDA's medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Healthcare provider or manufacturer coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Anesthesia Circuit Peds-LF
Model / REF:
DYNJAA0327F
DYNJAA0327G
Lot Numbers:
20LBV329
21FBM358
22CBY412
22GBZ157
22JBR268
23BBL309
23HBU238
23KBB605
24CBJ211
Product: Medline Baby Care Kit Univ
Model / REF:
DYKL1025
DYKL1025H
Lot Numbers:
21JBA955
21LBX335
22BBW368
22FBT155
22IBA604
22JBJ323
23ABH574
23ABS213
23CBT397
23FBI255
23GBF800
23IBN598
Product: Preop Nerve Block Tray
Model / REF:
DYNJRA2040H
Lot Numbers:
23CBH893
23HBX547
23JBN538
24ABQ696
24CBG746
Product: Peripheral Ultrasound Catheter Insertion Kit
Model / REF:
MNS9865
Lot Numbers:
2021111050
2022051050
23EMI898
2022060650
2022021850
2022041850
Product: Circumcision Tray / OSF SMMC Circumcision Kit
Model / REF:
CIT6715
CIT7095
CIT6780
CIT6920
DYNDA2271
Lot Numbers:
2023050590
2023091990
2022072650
2023101290
2023090790
2022111490
Product: Medline Open Heart / Vascular Packs
Model / REF:
CDS981050Q
CDS982411N
CDS983348AA
CDS983348X
CDS983348Y
CDS984206R
CMPJ01037P
CMPJ02162I
CMPJ03510J
CMPJ06631C
Lot Numbers:
23IBJ172
23IBH624
23IBI963
23FBN637
24ABM288
24ABR888
22GBA977
22KBB264
23BBR849
23CBM949
23DBB694
Product: Umbilical Line Kit W/Foam
Model / REF:
DYNDL1588A
Lot Numbers:
23ELA011
23HLA426
23JLA181
24ALA515
Product: Botox Kit - Chronic Migraine
Model / REF:
DYKM2000
Lot Numbers:
21FBO406
22DBI980
22KBD028
23JBC148
24ABL480
21ABM981
21BBR866

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94581
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized Medical Distributors; Hospitals; Clinics
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.