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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 and Centurion Convenience Kits Recalled for Potential Sterility Loss

Agency Publication Date: October 23, 2024
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Summary

Medline Industries, LP is recalling 100,579 units of Medline and Centurion brand medical procedure convenience kits due to a potential loss of sterility. These kits, used for various medical procedures such as tracheostomies, IV insertions, and surgeries, were packaged in a specific breather pouch (lot 323080002) that may have a compromised seal. If the seal is failing, the products inside could be non-sterile, which poses a serious infection risk during clinical use. No incidents or injuries have been reported to date.

Risk

A compromised pouch seal allows the medical instruments and components inside to be exposed to environmental contaminants. Using non-sterile medical devices during invasive procedures or surgeries can lead to serious patient infections or complications.

What You Should Do

  1. The recalled products are various Medline and Centurion medical procedure convenience kits including tracheostomy kits, suture trays, OB trays, anesthesia packs, and specialty surgical packs.
  2. Identify if your kit is affected by checking the REF (catalog) number and lot number printed on the outer label of the packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled kits immediately to prevent patient exposure to potentially non-sterile products.
  4. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for more information or to report a complaint.

Your Remedy Options

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

Affected Products

Product: Centurion PEDIATRIC/ADULT TRACHEOSTOMY T
Model / REF:
TC7895
Lot Numbers:
23LBM753
23KBD877
UDI:
40193489435246
10193489435245

Recall #: Z-0148-2025

Product: Centurion EP LAB INSTRUMENT KIT
Model / REF:
MNS10480
Lot Numbers:
23LBK889
UDI:
40653160307816
10653160307815

Recall #: Z-0149-2025

Product: Centurion FLOOR - UMBILICAL CUT DOWN TRA
Lot Numbers:
23LBO858
UDI:
40653160270929
10653160270928

Recall #: Z-0150-2025

Product: Centurion PLASTICS SUTURE TRAY
Lot Numbers:
23LBL653
UDI:
40653160284346
10653160284345

Recall #: Z-0150-2025

Product: Centurion OB TRAY
Model / REF:
MNS13965A
Lot Numbers:
24ABD184
UDI:
40653160995877
10653160995876

Recall #: Z-0151-2025

Product: Medline CV ANESTHESIA - ROOM SET UP
Model / REF:
DYNJ905503F
Lot Numbers:
23KBQ236
UDI:
40193489967273
10193489967272

Recall #: Z-0152-2025

Product: Medline PAIN PROCEDURE PACK
Model / REF:
DYNJ80370A
Lot Numbers:
23LBM330
UDI:
40195327388547
10195327388546

Recall #: Z-0153-2025

Product: Medline DR HEFZY BLOCK TRAY
Model / REF:
DYNJRA1854A
Lot Numbers:
23LBJ089
UDI:
40195327117062
10195327117061

Recall #: Z-0153-2025

Product: Medline SET UP PACK
Model / REF:
DYNJ36320A
Lot Numbers:
24ABC836
UDI:
40889942245230
10889942245239

Recall #: Z-0154-2025

Product: Medline ANGIOGRAM WRO-LF
Model / REF:
DYNJ41876B
Lot Numbers:
23LBM850
UDI:
40193489563086
10193489563085

Recall #: Z-0154-2025

Product: Medline RADIOLOGY LP TRAY
Model / REF:
DYNDH1609
Lot Numbers:
23LBO852
UDI:
40193489844802
10193489844801

Recall #: Z-0155-2025

Product: Medline CARDIAC CATH PACK-LF
Model / REF:
DYNJ19010I
Lot Numbers:
23LBK443
UDI:
40888277858627
10888277858626

Recall #: Z-0155-2025

Product: Medline SUPPLEMENTAL NEURO ANGIO PK
Model / REF:
DYNJ29207
Lot Numbers:
23LBL962
UDI:
40080196015413
10080196015412

Recall #: Z-0155-2025

Product: Medline ANGIO PACK
Model / REF:
DYNJ43661C
Lot Numbers:
23LBU931
UDI:
40195327104353
10195327104351

Recall #: Z-0155-2025

Product: Medline LEFT HEART CATH TEGH-LF
Model / REF:
DYNJ46746C
Lot Numbers:
23LBK374
UDI:
40195327040162
10195327040161

Recall #: Z-0155-2025

Product: Medline LFT HRT CATH RADIAL ACCESS-LF
Model / REF:
DYNJ47667C
Lot Numbers:
23LBL629
UDI:
40195327040179
10195327040178

Recall #: Z-0155-2025

Product: Medline IR ARM PACK
Model / REF:
DYNJ50712D
Lot Numbers:
23KBE846
UDI:
40195327267927
10195327267926

Recall #: Z-0155-2025

Product: Medline IR PACK
Model / REF:
DYNJ67324
Lot Numbers:
23LBL780
UDI:
40193489395625
10193489395624

Recall #: Z-0155-2025

Product: Medline PL. CATHETERISME CARDIAQUE
Model / REF:
HCT093J
Lot Numbers:
23LBG513
UDI:
40884389905679
10884389905678

Recall #: Z-0155-2025

Product: Medline CUH OPEN HEART A B C - CDS
Model / REF:
CDS983202I
Lot Numbers:
23LBI662
UDI:
40195327164677
10195327164676

Recall #: Z-0156-2025

Product: Medline PICC INSERTION KIT
Model / REF:
DYNDC2486A
Lot Numbers:
23LBM830
UDI:
40889942648055
10889942648054

Recall #: Z-0156-2025

Product: Medline OPEN HEART PACK
Model / REF:
DYNJ01201L
Lot Numbers:
23LBP126
UDI:
40888277744807
10888277744806

Recall #: Z-0156-2025

Product: Medline BREAST/CHEST SHEET PACK-LF
Model / REF:
DYNJ0537343G
Lot Numbers:
23LBP442
UDI:
40193489517072
10193489517071

Recall #: Z-0156-2025

Product: Medline COTTON ROLL KIT-LF
Model / REF:
DYNJ32727A
Lot Numbers:
24ABB296
UDI:
40888277036346
10888277036345

Recall #: Z-0156-2025

Product: Medline VASCULAR PACK-LF
Model / REF:
DYNJ32915B
Lot Numbers:
23LBK382
UDI:
40195327486427
10195327486426

Recall #: Z-0156-2025

Product: Medline SUAREZ AVR/MVR PACK
Model / REF:
DYNJ35884C
Lot Numbers:
24ABF463
UDI:
40195327547609
10195327547608

Recall #: Z-0156-2025

Product: Medline VALVE ACCESSORY PACK
Model / REF:
DYNJ36241K
Lot Numbers:
23LBL339
UDI:
40195327555949
10195327555948

Recall #: Z-0156-2025

Product: Medline ENSEMBLE ABDO-PERINEAL-LF
Model / REF:
DYNJ38084B
Lot Numbers:
23LBR317
UDI:
40889942670841
10889942670840

Recall #: Z-0156-2025

Product: Medline EP PACK
Model / REF:
DYNJ40488
Lot Numbers:
23LBL628
UDI:
40884389861685
10884389861684

Recall #: Z-0156-2025

Product: Medline PACEMAKER PACK SMGH-LF
Model / REF:
DYNJ41925G
Lot Numbers:
24ABA421
UDI:
40193489677349
10193489677348

Recall #: Z-0156-2025

Product: Medline PACEMAKER TEGH-LF
Model / REF:
DYNJ46745A
Lot Numbers:
23KBB860
UDI:
40889942279297
10889942279296

Recall #: Z-0156-2025

Product: Medline VEIN AND LASER PACK
Model / REF:
DYNJ49874
Lot Numbers:
23LBL699
UDI:
40888277890603
10888277890602

Recall #: Z-0156-2025

Product: Medline DR NACKMAN VEIN PACK
Model / REF:
DYNJ56235
Lot Numbers:
23EBD843A
UDI:
40889942621553
10889942621552

Recall #: Z-0156-2025

Product: Medline NEUROVASCULAR PACK
Model / REF:
DYNJ66718A
Lot Numbers:
24ABN915
UDI:
40193489916332
10193489916331

Recall #: Z-0156-2025

Product: Medline VEIN TRAY
Model / REF:
DYNJ69012C
Lot Numbers:
23LBQ949
UDI:
40195327515943
10195327515942

Recall #: Z-0156-2025

Product: Medline LOOP RECORDER-LF
Model / REF:
DYNJ69196
Lot Numbers:
23LBR843
UDI:
40193489906234
10193489906233

Recall #: Z-0156-2025

Product: Medline U BAR DRAPE
Model / REF:
DYNJ80064
Lot Numbers:
23LBP174
UDI:
40195327009251
10195327009250

Recall #: Z-0156-2025

Product: Medline ENDO
Model / REF:
DYNJ903814B
Lot Numbers:
23LBS865
UDI:
40195327333769
10195327333768

Recall #: Z-0156-2025

Product: Medline CARDIAC PROCEDURE
Model / REF:
DYNJ908126
Lot Numbers:
24BBA256
24ABN040
UDI:
40193489980111
10193489980110
40193489374378
10193489374377

Recall #: Z-0156-2025

Product: Medline VASCULAR EXTREMITY PACK
Model / REF:
SYNJ10322A
Lot Numbers:
24ABD377
UDI:
40193489374378
10193489374377

Recall #: Z-0156-2025

Product: Medline VASCULAR EXTREMITY
Model / REF:
SYNJ910026A
Lot Numbers:
24ABV352
UDI:
40193489374491
10193489374490

Recall #: Z-0156-2025

Product: Medline KIT LINE INSERTION
Model / REF:
CVI4730A
Lot Numbers:
24ABK903
23LBN351
UDI:
40195327562039
10195327562038

Recall #: Z-0157-2025

Product: Medline LINE INSERTION TRAY
Model / REF:
DYNJ20803D
Lot Numbers:
24ABE939
UDI:
40889942553885
10889942553884

Recall #: Z-0157-2025

Product: Medline CENTRAL LINE PACK-LF
Model / REF:
DYNJ28368
Lot Numbers:
24ABD995
23KBE939
UDI:
40080196200161
10080196200160

Recall #: Z-0157-2025

Product: Medline PICC PACK-LF
Model / REF:
DYNJ28487
DYNJ28487H
Lot Numbers:
24ABI626
UDI:
40080196227021
10080196227020

Recall #: Z-0157-2025

Product: Medline CENTRAL LINE PACK
Model / REF:
DYNJ30087C
Lot Numbers:
23JBS113
UDI:
40889942754145
10889942754144

Recall #: Z-0157-2025

Product: Medline CENTRAL LINE ADULT PACK
Model / REF:
DYNJ35352
Lot Numbers:
23LBN154
UDI:
40884389433080
10884389433089

Recall #: Z-0157-2025

Product: Medline PICC PACK
Model / REF:
DYNJ52255
DYNJ69088A
Lot Numbers:
24ABC063
23LBP745
UDI:
40889942253709
10889942253708
40193489975247
10193489975246

Recall #: Z-0157-2025

Product: Medline PICC PROCEDURE PACK
Model / REF:
DYNJ59067A
Lot Numbers:
24ABC903
23LBM072
UDI:
40195327421282
10195327421281

Recall #: Z-0157-2025

Product: Medline DR SIRAGUSA VEIN PACK
Model / REF:
DYNJ61247A
Lot Numbers:
23LBN198
UDI:
40195327492862
10195327492861

Recall #: Z-0157-2025

Product: Medline PICC TEAM PACK
Model / REF:
DYNJ64542A
Lot Numbers:
23LBN027
UDI:
40193489293723
0193489293722

Recall #: Z-0157-2025

Product: Medline PICC LINE INSERTION PACK
Model / REF:
DYNJ65519
Lot Numbers:
24ABE345
UDI:
40193489283939
10193489283938

Recall #: Z-0157-2025

Product: Medline CVL INSERTION KIT II PGYBK
Model / REF:
DYNJ68112
Lot Numbers:
24ABH428
23LBT018
UDI:
40193489498906
10193489498905

Recall #: Z-0157-2025

Product: Medline PICC INSERTION TRAY
Model / REF:
DYNJ80031
Lot Numbers:
23LBN003
UDI:
40195327007745
10195327007744

Recall #: Z-0157-2025

Product: Medline ENDOVENOUS ABLATION PACK
Model / REF:
DYNJ80489A
Lot Numbers:
23LBP033
UDI:
40195327582723
10195327582722

Recall #: Z-0157-2025

Product: Medline CVR ENDOVENOUS PACK
Model / REF:
DYNJ80643
Lot Numbers:
23KBK131
UDI:
40195327055791
10195327055790

Recall #: Z-0157-2025

Product: Medline RADIAL ARTERY PACK
Model / REF:
DYNJ83938
Lot Numbers:
24ABG864
UDI:
40195327317233
101953273172329

Recall #: Z-0157-2025

Product: Medline CONE BIOPSY PACK
Model / REF:
DYNJ17534L
Lot Numbers:
23KBF936
UDI:
40195327258253
10195327258252

Recall #: Z-0158-2025

Product: Medline BIOPSY TRAY
Model / REF:
DYNJ43076A
Lot Numbers:
23LBI584
UDI:
40195327080625
10195327080624

Recall #: Z-0158-2025

Product: Medline LOU LOOP RECORDER PACK
Model / REF:
DYNJ49404C
Lot Numbers:
23LBP833
UDI:
40195327395453
10195327395452

Recall #: Z-0158-2025

Product: Medline CT BIOPSY
Model / REF:
DYNJ52666C
Lot Numbers:
23LBN740
UDI:
40193489452144
10193489452143

Recall #: Z-0158-2025

Product: Medline BIOPSY KIT
Model / REF:
DYNJ61130B
Lot Numbers:
23LBP401
UDI:
40195327054589
10195327054588

Recall #: Z-0158-2025

Product: Medline ASPEN SOFT TISSUE PACK
Model / REF:
DYNJ63165B
Lot Numbers:
23KBD517
UDI:
40193489461580
10193489461589

Recall #: Z-0158-2025

Product: Medline BIOPSY TRAY FOAKS
Model / REF:
DYNJ63575A
Lot Numbers:
23LBR787
UDI:
40193489429337
10193489429336

Recall #: Z-0158-2025

Product: Medline CUSTOM SOFT TISSUE PACK
Model / REF:
DYNJ66347A
Lot Numbers:
24ABA444
UDI:
40193489884716
10193489884715

Recall #: Z-0158-2025

Product: Medline KWIK PACK
Model / REF:
DYNJ67926B
Lot Numbers:
23LBL347
UDI:
40195327519514
10195327519513

Recall #: Z-0158-2025

Product: Medline ESI TRAY
Model / REF:
DYNJ68261B
Lot Numbers:
24ABA492
UDI:
40195327513369
10195327513368

Recall #: Z-0158-2025

Product: Medline LARGE BIOPSY PACK NTX
Model / REF:
DYNJ68393A
Lot Numbers:
23LBL431
UDI:
40193489939997
10193489939996

Recall #: Z-0158-2025

Product: Medline LOOP KIT
Model / REF:
DYNJ84129
Lot Numbers:
23KBB926
UDI:
40195327334544
10195327334543

Recall #: Z-0158-2025

Product: Medline DENTAL PACK
Model / REF:
DYNJ64086B
Lot Numbers:
24ABF266
UDI:
40195327120420
10195327120429

Recall #: Z-0159-2025

Product: Medline CENTRAL CATHETER INSERTION TRA
Model / REF:
CVI680C
Lot Numbers:
23LBO846
UDI:
40653160992944
10653160992943

Recall #: Z-0162-2025

Product: Medline DIALYSIS PACK
Model / REF:
DYNJ36932A
Lot Numbers:
23LBL499
UDI:
40195327429752
10195327429751

Recall #: Z-0163-2025

Product: Medline CHEST TUBE INSERTION TRAY ADUL
Model / REF:
CHT1165
Lot Numbers:
24ABB506
UDI:
40653160273586
10653160273585

Recall #: Z-0167-2025

Product: Medline IV TEAM PICC
Model / REF:
DYNJ48222
Lot Numbers:
23LBS908
UDI:
40888277567925
10888277567924

Recall #: Z-0168-2025

Product: Medline PEDIATRIC DRAPE PK
Model / REF:
DYNJ81297
Lot Numbers:
23LBL738
UDI:
40195327108084
10195327108083

Recall #: Z-0169-2025

Product: Medline TUBAL LIGATION PACK
Model / REF:
DYNJ66230B
Lot Numbers:
24ABG688
UDI:
40195327206087
10195327206086

Recall #: Z-0170-2025

Product: Medline AMBULATORY MINI PACK
Model / REF:
DYNJ82579
Lot Numbers:
23LBO804
UDI:
40195327198153
10195327198152

Recall #: Z-0172-2025

Product: Medline EYE PACK
Model / REF:
LYN036EPESB
Lot Numbers:
24ABA894
UDI:
40889942863304
10889942863303

Recall #: Z-0180-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95415
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medical distributors; Hospitals; Clinical facilities
Manufactured In: United States
Units Affected: 33 products (30 units; 90 units; 168 units; 30 units; 15 units; 320 units; 312 units; 1460 units; 2631 units; 5238 units; 2,426 units; 165 units; 2740 units; 5972 units; 1180 units; 90 units; 8830 units; 1048 units; 22,327 units; 15 units; 120 units; 150 units; 22 units; 194 units; 144 units; 51 units; 12,583 units; 197 units; 88 units; 1506 units; 27,906 units; 2371 units; 160 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.

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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.