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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 Surgical Patties and Strips Recalled for High Endotoxin Levels

Agency Publication Date: December 20, 2024
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Summary

Medline Industries, LP has recalled 42,946 medical procedure convenience kits containing Medline brand Codman surgical patties and strips. These kits, used in neurosurgical and ENT (ear, nose, and throat) procedures, were found to contain higher-than-expected levels of endotoxins in the raw material used to make the surgical tools. Endotoxins are bacterial toxins that can cause serious complications if they enter a patient's body during surgery. No injuries or incidents have been reported at this time.

Risk

The presence of out-of-specification endotoxin levels in sterile surgical materials can cause severe inflammatory reactions, high fever, or other systemic complications during or after an operation.

What You Should Do

  1. This recall involves Medline brand medical procedure convenience kits including Major Neuro Packs, FESS packs, Nasal packs, and various Sinus, ENT, Craniotomy, and Spine packs containing surgical patties and strips.
  2. Identify if you have the recalled product by checking the SKU, lot number, and UDI-DI code on the kit packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled surgical kits immediately and remove them from clinical inventory.
  4. Contact Medline Industries, LP or your medical distributor to arrange for the return, replacement, or correction of the affected kits.
  5. Call the FDA at 1-888-463-6332 or visit the FDA's website at www.fda.gov for additional questions or to report a safety concern.

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: MAJOR NEURO PACK-LF Convenience kit
Model / REF:
DYNJ0578916X
Lot Numbers:
23AMD730
UDI:
10193489288384
40193489288385

Recall #: Z-0717-2025

Product: FESS-MB PACK-LF Convenience kit
Model / REF:
DYNJ0888159I
Lot Numbers:
23HMB316
UDI:
10195327050146
40195327050147

Recall #: Z-0718-2025

Product: DIEP FLAP Convenience kit
Model / REF:
DYNJ910120
Lot Numbers:
24CMH776
UDI:
10195327589202
40195327589203

Recall #: Z-0719-2025

Product: SINUS CDS-1
Model / REF:
CDS982901F
Lot Numbers:
23HBQ152
UDI:
10889942216970
40889942216971

Recall #: Z-0720-2025

Product: NASAL PACK
Model / REF:
DYNJ17493G
Lot Numbers:
23GBW775
UDI:
10195327224424
40195327224425

Recall #: Z-0720-2025

Product: FESS PACK-POB
Model / REF:
DYNJ33520A
Lot Numbers:
23HDB834
UDI:
10884389851333
40884389851334

Recall #: Z-0720-2025

Product: SINUS PACK
Model / REF:
DYNJ44845G
Lot Numbers:
23HBF195
UDI:
10889942712311
40889942712312

Recall #: Z-0720-2025

Product: SINUS PACK
Model / REF:
DYNJ48330B
Lot Numbers:
23HBO622
UDI:
10195327113506
40195327113507

Recall #: Z-0720-2025

Product: ENT PACK
Model / REF:
DYNJ50572
Lot Numbers:
23GBR940
UDI:
10889942008476
40889942008477

Recall #: Z-0720-2025

Product: ENT PACK
Model / REF:
DYNJ53573A
Lot Numbers:
23GBS356
UDI:
10193489201635
40193489201636

Recall #: Z-0720-2025

Product: ENT HUTCH
Model / REF:
DYNJ58856A
Lot Numbers:
23HBO870
UDI:
10193489750263
40193489750264

Recall #: Z-0720-2025

Product: PACK NASAL
Model / REF:
DYNJ60111A
Lot Numbers:
21JMB783
21HMF433
21GMD178
21FMC923
20IMB575
UDI:
10193489246995
40193489246996

Recall #: Z-0720-2025

Product: PACK NASAL
Model / REF:
DYNJ60111B
Lot Numbers:
24HMC974
24GMA899
24FMB079
24EMC108
24DMD791
24CMG320
UDI:
10195327527617
40195327527618

Recall #: Z-0720-2025

Product: ENT CUSTOM PACK
Model / REF:
DYNJ63052C
Lot Numbers:
22KME394
22KMA630
22JMD852
22GMG160
22EMG974
22DMF954
22CMC565
UDI:
10195327101312
40195327101313

Recall #: Z-0720-2025

Product: ENT PACK
Model / REF:
DYNJ64256D
Lot Numbers:
23HBA766
UDI:
10195327452773
40195327452774

Recall #: Z-0720-2025

Product: FESS/SEPTOPLASTY PACK
Model / REF:
DYNJ64509B
Lot Numbers:
23HBC092
UDI:
10195327323745
40195327323746

Recall #: Z-0720-2025

Product: SINUS ENDOSCOPY PACK
Model / REF:
DYNJ65644
Lot Numbers:
23HBA753
UDI:
10193489283204
40193489283205

Recall #: Z-0720-2025

Product: ACOUSTICS SHSC-LF
Model / REF:
DYNJ66749
Lot Numbers:
21ABT938
21ABO570
20JBS998
20HBM389
UDI:
10193489375947
40193489375948

Recall #: Z-0720-2025

Product: TRANSPHENOIDAL PACK
Model / REF:
DYNJ67423A
Lot Numbers:
24DLA092
24BLA235
23KLA058
23ILB043
23ILA503
23HLB296
23HLB011
23FLA068
23DLA463
23DLA185
23BLA617
22LLA582
22KLA652
22HLA029
22GLA884
UDI:
10195327163402
40195327163403

Recall #: Z-0720-2025

Product: TRANSPHENOIDAL PACK
Model / REF:
DYNJ67423B
Lot Numbers:
24GLB018
24FLA258
24ELA763
24DLA759
UDI:
10195327686871
40195327686872

Recall #: Z-0720-2025

Product: ENT PACK
Model / REF:
DYNJ68102B
Lot Numbers:
24IBB348
24GBB791
24EBA114
UDI:
10195327699369
40195327699360

Recall #: Z-0720-2025

Product: E N T PACK
Model / REF:
DYNJ80526B
Lot Numbers:
23HBF568
UDI:
10195327211059
40195327211050

Recall #: Z-0720-2025

Product: NASAL PACK
Model / REF:
DYNJ81280
Lot Numbers:
22HMF910
UDI:
10195327102968
40195327102969

Recall #: Z-0720-2025

Product: ENT FESS PACK
Model / REF:
DYNJ81420A
Lot Numbers:
24CBL416
23LBK136
23IBR308
23HBD265
23GBJ044
23FBK113
23EBN716
23BBQ143
UDI:
10195327322601
40195327322602

Recall #: Z-0720-2025

Product: HEAD AND NECK PACK
Model / REF:
DYNJ81934
Lot Numbers:
23EBG024
23BBC727
22JBJ632
22HBH399
UDI:
10195327156817
40195327156818

Recall #: Z-0720-2025

Product: HEAD AND NECK PACK - 51597
Model / REF:
DYNJ81934A
Lot Numbers:
24DBK564
24DBB486
24CBG998
24BBV700
24ABD320
23HBO084
23GBG012
UDI:
10195327413019
40195327413010

Recall #: Z-0720-2025

Product: HEAD AND NECK ENT PACK
Model / REF:
DYNJ83679A
Lot Numbers:
24HBP441
24GBF665
24BBO428
23LBS373
23JBD663
23IBN314
UDI:
10195327459727
40195327459728

Recall #: Z-0720-2025

Product: HEAD NECK PACK HC
Model / REF:
DYNJ84270
Lot Numbers:
23GBC274
UDI:
10195327349103
40195327349104

Recall #: Z-0720-2025

Product: TRANSPHENOIDAL PACK-LF
Model / REF:
DYNJ85422
Lot Numbers:
24FDA925
24ADB100
UDI:
10195327499716
40195327499717

Recall #: Z-0720-2025

Product: NASAL SEPTAL
Model / REF:
DYNJ901299A
Lot Numbers:
21FBC250
20JBO761
20IBH831
20FBM501
UDI:
10889942010349
40889942010340

Recall #: Z-0720-2025

Product: NASAL SEPTAL
Model / REF:
DYNJ901299B
Lot Numbers:
22FBU440
22OBC118
22OBC120
22ABA377
21JBJ197
21IBM868
21GBO441
UDI:
10193489923384
40193489923385

Recall #: Z-0720-2025

Product: PACK TRANSPHENOIDAL
Model / REF:
DYNJ905685D
Lot Numbers:
24IDB382
UDI:
10198459024139
40198459024130

Recall #: Z-0720-2025

Product: SEPTOPLASTY
Model / REF:
DYNJ906474C
Lot Numbers:
24HDA228
24EDA811
24DDB542
23LDB493
23GDA771
23DDA732
22IDB976
UDI:
10195327221355
40195327221356

Recall #: Z-0720-2025

Product: LEFORTE MANDIBLE
Model / REF:
DYNJ906839A
Lot Numbers:
22JMB394
UDI:
10195327092528
40195327092529

Recall #: Z-0720-2025

Product: NASAL MHS
Model / REF:
DYNJ908545A
Lot Numbers:
23JBV681
UDI:
10195327384166
40195327384167

Recall #: Z-0720-2025

Product: NASAL MHS
Model / REF:
DYNJ908545B
Lot Numbers:
24HBI988
24FBS776
24FBA297
24ABT058
UDI:
10195327593124
40195327593125

Recall #: Z-0720-2025

Product: ENT
Model / REF:
DYNJ909128A
Lot Numbers:
23EBD903
23DBD851
UDI:
10195327326739
40195327326730

Recall #: Z-0720-2025

Product: ENT
Model / REF:
DYNJ909128C
Lot Numbers:
23JBO251
23HBI313
UDI:
10195327458416
40195327458417

Recall #: Z-0720-2025

Product: ENT
Model / REF:
DYNJ909128D
Lot Numbers:
24EBC023
24CBK211
24BBM816
24ABR742
23LBQ695
23LBM416
UDI:
10195327516321
40195327516322

Recall #: Z-0720-2025

Product: ENT
Model / REF:
DYNJ909128F
Lot Numbers:
24HBV054
24GBN495
UDI:
10198459055256
40198459055257

Recall #: Z-0720-2025

Product: SINUS PACK
Model / REF:
DYNJ909370
Lot Numbers:
24BMA818
24AMG256
23LMF420
23LMB722
23LMA458
23CME287
UDI:
10195327319038
40195327319039

Recall #: Z-0720-2025

Product: MVFF/FIBU #54-RF
Model / REF:
DYNJ21927R
Lot Numbers:
23IBF547
23GBT501
23FBU360
23EBU929
23EBL624
23EBA114
23CBN730
23ABF393
22JBK203
22IBN858
22HBO301
22GBC794
22CBI774
UDI:
10195327104733
40195327104734

Recall #: Z-0721-2025

Product: DIEP FLAP
Model / REF:
DYNJ910120A
Lot Numbers:
24HMK254
UDI:
10195327689872
40195327689873

Recall #: Z-0721-2025

Product: SEPTOPLASTY PACK Convenient kit
Model / REF:
DYNJ44759F
Lot Numbers:
20JBD814
UDI:
10193489789935
40193489789936

Recall #: Z-0722-2025

Product: CRANIOTOMY
Model / REF:
CDS982719X
Lot Numbers:
24IBE288
UDI:
10198459064531
40198459064532

Recall #: Z-0723-2025

Product: MVFF/FIBU #54-RF
Model / REF:
DYNJ21927Q
Lot Numbers:
21LBB957
21KBA966
21IBN569
21GBO771
20KBB297
20JBB045
20IBI973
20HBU423
20HBC730
20EBU633
UDI:
10889942885534
40889942885535

Recall #: Z-0723-2025

Product: MVFF/FIBU #54-RF
Model / REF:
DYNJ21927S
Lot Numbers:
24GBQ357
24GBK331
24FBF951
24CBV435
24BBN342
24ABW268
UDI:
10195327576233
40195327576234

Recall #: Z-0723-2025

Product: KIT,SPINE LH Convenience kit
Model / REF:
DYNJ906448A
Lot Numbers:
21EBG271
21CBS664
20LBO883
20WBE707
UDI:
10193489408508
40193489408509

Recall #: Z-0725-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95806
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Surgical Centers; Medical distributors
Manufactured In: United States
Units Affected: 9 products (40 kits; 36 kits; 26 kits; 6467 kits; 318 kits; 40 kits; 12,889 kits; 160 kits; 22,970 kits)
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.