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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 Medical Convenience Kits Recalled for Syringe Leaks and Breakage

Agency Publication Date: March 26, 2025
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Summary

Medline Industries, LP is recalling 19,552 medical convenience kits, including various procedure-specific packs such as ENT, plastic surgery, neurosurgical, and orthopedic kits. The plastic syringes included in these kits may leak, break, or fail, posing a risk to patient health during surgical or medical procedures. This voluntary recall follows a broader FDA Safety Alert regarding quality issues with certain plastic syringes. The affected kits were distributed worldwide to hospitals, surgical centers, and medical supply distributors.

Risk

Defective syringes may leak or break during use, potentially causing procedure delays or improper delivery of fluids and medications. These failures could compromise patient safety and clinical outcomes.

What You Should Do

  1. This recall involves Medline procedure kits including ENT packs, plastic surgery kits, angiography specials, neurosurgery packs, and orthopedic or arthroscopy kits sold under many specific procedure names.
  2. Identify affected kits by checking the kit name, pack number, lot number, and Unique Device Identifier (UDI) on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical convenience kits immediately.
  4. Contact Medline Industries or your medical supply distributor to arrange for the return, replacement, or correction of any affected products.
  5. For further questions or to report quality issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline ENT and Thoracic Procedure Kits
Variants: BILLINGS CLINIC SC HEAD & NECK, BLEPH/RHINO PACK, DB ENT CSTM PACK-LF, DENTAL PACK, EAR PACK, ENT HEAD NECK PACK, ENT PACK, EP PACK, FUNCTIONAL ENDO SINUS WEILER, HEAD & NECK PACK, NASAL SINUS PACK-LF, NE NASAL, ORL PACK, SINUS PACK, T & A PACK, THORACIC PACK, THYROIDECTOMIE DIAGNOSTIQUE-LF, TONSILS & ADENOIDS, TRANSPHENOIDAL PACK
Model / REF:
DYNJ33656C
DYNJ64669A
DYNJ33585C
DYNJ54064
DYNJ68678C
DYNJ49023D
DYNJ42564B
DYNJ50572
DYNJ45175B
DYNJ65585A
DYNJ59171
DYNJ58857A
DYNJ902987F
DYNJ61295B
DYNJ30234B
DYNJ50383
DYNJ36634K
DYNJ66399
DYNJ38402I
DYNJ0161710I
DYNJ0751486N
DYNJ03130D
DYNJ63705B
DYNJ50110B
DYNJ58811A
DYNJ30731M
DYNJ42678A
DYNJ69465
DYNJ46556B
Lot Numbers:
20BDA583A
20BDB113A
20FBS559A
20FMA565A
20HKB321A
20HMC644A
20HMD066A
20HMD167A
20JKA848A
20LBI228Z
20LBS935Z
21BBI544A
21IMD870A
21IME024A
21IME395A
21IME484A
21IME728A
21IME769A
21IMH101A
22FBW094A
22GBL783M
22GBM456Z
22GMA060Z
22JBY434A
22KBC920Z
23CBN716A
23CBO497A
23CDC561A
23CLA003A
23GMC950A
UDI:
10889942278022
10193489682212
10193489369892
10888277546394
10193489258936
10193489531589
10193489296792
10888277756168
10193489366815
10193489718577
10193489397598
10193489805413
10193489551068
10193489909869
10193489322644
10889942575701
10193489976625
10889942651887
10193489303940
10193489917703
10195327176310
10195327155780
10889942275069
10195327230081
10193489276510
10888277208872
10195327040239
10195327026592
10195327299064
10195327383596

Recall #: Z-1461-2025

Product: Medline Plastic and Ocular Surgery Procedure Kits
Variants: BREAST PACK-LF, BREAST SURGERY FOAKS, CHEST BREAST -LF, DIEP PACK, FACE LIFT PACK, FREE FLAP A PACK, IPMC BREAST PACK-LF, OCULAR PLASTICS PACK, OCULOPLASTY PACK-LF, PACK MASTECTOMY COMBO CHRG, PLASTIC GENERAL SURGERY - OSC, PLASTIC PACK, PLASTIC PK II, PLASTIC-GENERAL SURGERY PACK, PLASTICS FACIAL PACK ST MARY, PLASTICS PACK
Model / REF:
DYNJ0956628O
DYNJ63577C
DYNJCEN04C
DYNJ60669G
DYNJ64670B
DYNJ40647G
DYNJ0665560D
DYNJ40356A
DYNJ0252232U
DYNJ60232A
DYNJ43576A
DYNJ00264L
DYNJ49742B
DYNJ14039B
DYNJ09866U
DYNJ45861B
DYNJ68288A
Lot Numbers:
21BBH575A
21BBI089A
21BBI544A
21EME131A
21IME484A
21IMH836A
22CMB464A
22JBF484Z
22JBG465Z
22JBN921Z
22JBU153Z
22JBU265A
22JBV346A
22JBW642A
22JBY434A
22KBC920Z
22KBC927Z
UDI:
10193489785869
10193489267143
10193489805413
10889942794942
10889942575701
10193489270976
10195327089795
10193489228335
10195327217334
10195327222451
10193489920116
10193489801866
10195327210267
10193489324495
10195327230081
10193489276510

Recall #: Z-1462-2025

Product: Medline Angiography Specials Kits
Variants: ANGIOGRAPHY SPECIALS
Model / REF:
DYNJ60655D
Lot Numbers:
24AMC692A
UDI:
10195327464783

Recall #: Z-1463-2025

Product: Medline Neurosurgical Procedure Kits
Variants: ACOUSTIC NEUROMA PACK-LF, ANGIOGRAPHY PACK, NEURO ANGIO PACK, NEURO ANGIO PACK SJF-LF, NEURO PACK, SNI NEURO, VP SHUNT PACK
Model / REF:
DYNJ37741B
DYNJ21519W
DYNJ83941
DYNJ55678
DYNJ04851Q
DYNJ45379D
DYNJ55558C
Lot Numbers:
20BDB113A
20BDB225A
22JBA879Z
22JBC551Z
22JBC798Z
23FME560A
23LMG468A

Recall #: Z-1464-2025

Product: Medline Orthopedic and Arthroscopy Procedure Kits
Variants: ACL ARTHROSCOPY PACK, ARTERIOGRAM PACK, ARTHRO PACK-LF, ARTHROGRAM PACK, ARTHROGRAM TRAY, ARTHROSCOPY KNEE PACK-LF, ARTHROSCOPY PACK, ARTHROSCOPY TRAY, BACK PACK-LF, BASIC ORTHO PACK, BASIC SPINE PACK-LF, CLOVIS LOWER EXTREMITY-LF, CRANIOTOMY PACK, DL-KNEE SCOPE, ENSEMBLE CRANIOTOMIE-LF, ESC HAND PACK, EXTREMITY PACK, FOOT AND ANKLE PACK, GENERAL ORTHO PACK-LF, HAND PACK, HIP PACK
Model / REF (204):
DYNJ55316G
DYNJ64332
DYNJ38748F
DYNJ65817
DYNDH1937
DYNJ0809731F
DYNJ66665
DYNJ38716C
DYNJ33639J
DYNJ37707D
DYNJ38914A
DYNJ64526A
DYNJ62755B
DYNJ61634B
DYNJ83129
DYNJ35906F
DYNJ37946C
DYNJ68133A
DYNJ45629B
DYNJ0781838S
DYNJ80469B
DYNJ04452L
DYNJ24507G
DYNJ65948A
DYNJ81547
DYNJ0381507N
DYNJ67212A
DYNJ39199F
DYNJ61066C
DYNJ45145G
DYNJ0530906AO
DYNJ38351O
DYNJ67595B
DYNJ29202D
DYNJ42264
DYNJ52017
DYNJ64167D
DYNJ52104A
DYNJ53915D
DYNJ35046B
DYNJ83732
DYNJ54684B
DYNJ44692D
DYNJ0190688Q
DYNJ30196F
DYNJ51796G
DYNJ39734D
DYNJ65319B
DYNJ0781892X
DYNJ0163462Y
Lot Numbers (210):
20BDA583A
20BDB394A
20BDB587A
20BDB606A
20EBL095A
20FBS286Z
20FBS559A
20FMA565A
20GBA802Z
20GKA136A
20HKB321A
20HKB355A
20HMC644A
20HMD066A
20HMD167A
20JKA848A
20LBI228Z
20LBS935Z
20LKB368A
20LMF345A
21ABK027A
21AMA194A
21AMA323A
21AMA358A
21AMA575A
21AMA586A
21AMA587A
21BBB671A
21BBF422A
21BBF515A
21CBB429A
21EBL376Z
21EBL427A
21EBM957A
21GMB024A
21GMB048A
21HMA483A
21HMA492A
21HMA631A
21IMC899A
21IMD192A
21IMD397A
21IMD680A
21IMD870A
21IME024A
21IME395A
21IME728A
21IME769A
21IMH101A
21IMH684A
UDI (209):
10889942278022
10889942692262
10193489275063
10889942524334
10193489744910
10193489773088
10193489369892
10888277546394
10193489706796
10193489783247
10193489258936
10193489265651
10193489531589
10193489296792
10888277756168
10193489366815
10193489718577
10193489397598
10193489338829
10193489408188
10193489354010
10193489509175
10889942935567
10193489408034
10193489443387
10889942794942
10889942954957
10193489422511
10193489662825
10193489733631
10193489845983
10193489685046
10193489869040
10193489295160
10193489551488
10889942008476
10889942598595
10884389918845
10888277048713
10193489567618
10889942487493
10193489867442
10193489822564
10193489551068
10193489909869
10193489322644
10193489976625
10889942651887
10193489303940
10193489249408

Recall #: Z-1465-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96373
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Specialty Healthcare Providers; Medical Supply Distributors; Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 5 products (2161 kits; 1228 units; 1152 units; 422; 14589 units)
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 ยท 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.