Skip to main content

FDA recall, , Moderate risk

Medline Convenience Kits

Medline Convenience Kits contain lidocaine ampules with quality issues that may affect their use.

What happened

Medline Industries, LP of Northfield, Illinois, recalled Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules, following a recall notice issued by Huons Co., Ltd. due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. The recall began May 21, 2026, and was added to FDA's Enforcement Report on June 29, 2026. The kits were distributed nationwide.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Match your product and all the details in one listed combination.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. 3" 20G Radial Arterial Line Kit-ICU

    Model
    • ART240C
    UDI-DI
    • 10653160373322
    Lot code
    • 2025112590
    • 2025090490
  2. 3L 7F 20CM CVC Insertion Kit

    Model
    • ECVC8465
    UDI-DI
    • 10653160372141
    Lot code
    • 2025112090
  3. 3L 7FR 16 cm CVC Insertion Tray

    Model
    • ECVC8165
    UDI-DI
    • 10653160358749
    Lot code
    • 2025101390
  4. 3L 7FR 16CM CVC Insertion Bundle

    Model
    • ECVC7605
    UDI-DI
    • 10653160364498
    Lot code
    • 2026010890
    • 2025103090
  5. 3L 7FR 20CM CVC Insertion Bundle

    1. Model
      • ECVC6845
      UDI-DI
      • 10653160339366
      Lot code
      • 2025091590
    2. Model
      • ECVC7600
      UDI-DI
      • 10653160364443
      Lot code
      • 2026010790
  6. 7F, 16cm, 3L Max Barrier CVC Bundle

    Model
    • ECVC5480
    UDI-DI
    • 10653160380368
    Lot code
    • 2025122290
  7. 7FR 3L 16CM CVC Insertion Bundle

    Model
    • ECVC8215
    UDI-DI
    • 10653160358992
    Lot code
    • 2025101790
  8. 7FR 3L 20CM CVC Insertion BNDL

    Model
    • ECVC7830C
    UDI-DI
    • 10653160374480
    Lot code
    • 2025112490
    • 2025091990
  9. 8.5F 4L 20CM CVC + Bundle

    Model
    • ECVC8640
    UDI-DI
    • 10653160390848
    Lot code
    • 2025122390
  10. 8.5F 16cm Double Lumen CVC Bundle

    Model
    • ECVC5490
    UDI-DI
    • 10653160363309
    Lot code
    • 2025120390
Show the other 123 products
  1. 16CM Triple Lumen 7FR Insert Bundle

    Model
    • ECVC2555
    UDI-DI
    • 10653160336570
    Lot code
    • 2025121190
  2. 20CM 7F 3L CVC Max Barrier Insertion

    Model
    • ECVC1970B
    UDI-DI
    • 10653160362975
    Lot code
    • 2025120490
  3. 20CM, 3L Insert Bundle-Cincinnati VA

    Model
    • ECVC3505
    UDI-DI
    • 10653160364467
    Lot code
    • 2025120590
    • 2025093090
  4. 20G x 6" Arterial Catheter Kit

    Model
    • ART356
    UDI-DI
    • 10653160375371
    Lot code
    • 2026011990
    • 2025101390
  5. 20GX3" Radial ART Line Kit

    Model
    • ART351
    UDI-DI
    • 10653160323754
    Lot code
    • 2025120990
    • 2025112690
    • 2025101090
  6. 20GX6" Femoral ART Line Kit

    Model
    • ART352
    UDI-DI
    • 10653160323747
    Lot code
    • 2025100790
  7. A Line Kit, 20G

    Model
    • ART1303
    UDI-DI
    • 10653160390268
    Lot code
    • 2025112690
  8. A Line Tray

    Model
    • ART690
    UDI-DI
    • 10653160318019
    Lot code
    • 2025120390
  9. A-Line Kit, No Cath

    Model
    • ARTNC217
    UDI-DI
    • 10653160383352
    Lot code
    • 2025121190
  10. Arterial Access Tray W/Lidocaine

    Model
    • ART1145
    UDI-DI
    • 10653160349259
    Lot code
    • 2025120590
    • 2025101490
  11. Arterial Line Insertion Tray

    Model
    • ART1010B
    UDI-DI
    • 10653160353577
    Lot code
    • 2025091590
  12. Arterial Line Kit

    Model
    • ART890B
    UDI-DI
    • 10653160360834
    Lot code
    • 2025102390
  13. Arterial Line Tray

    1. Model
      • ART350
      UDI-DI
      • 10653160362050
      Lot code
      • 2025120890
    2. Model
      • ART600
      UDI-DI
      • 10653160312727
      Lot code
      • 2025112690
  14. Arthrogram Tray

    Model
    • SPEC0070B
    UDI-DI
    • 10193489196627
    Lot code
    • 2025100890
  15. AVA High Flow

    Model
    • ECVC3720
    UDI-DI
    • 10653160341499
    Lot code
    • 2025123090
    • 2025101690
  16. Basic Biopsy Tray

    Model
    • SPEC0051
    UDI-DI
    • 10653160387503
    Lot code
    • 2025120290
    • 2025100790
  17. Biopsy Pack

    1. Model
      • DYNDH1135B
      UDI-DI
      • 10653160387459
      Lot code
      • 2025120390
    2. Model
      • DYNDH1699
      UDI-DI
      • 10653160349914
      Lot code
      • 2025092590
  18. Biopsy Tray

    1. Model
      • MNS7065A
      UDI-DI
      • 10193489196566
      Lot code
      • 2025120190
    2. Model
      • DYNDH1466
      UDI-DI
      • 10193489193756
      Lot code
      • 2025102190
  19. Block Tray

    Model
    • DYNJRA1590
    UDI-DI
    • 10193489284829
    Lot code
    • 25JLA522
  20. Breast Biopsy Pack

    Model
    • PHS234706I
    UDI-DI
    • 10198459330278
    Lot code
    • 25JLB029
  21. CDP, mm, 3L, 7F, 16CM, H

    Model
    • 3K16H1838
    UDI-DI
    • 10653160341260
    Lot code
    • 2025120590
    • 2025092490
  22. Central Line Bundle W/7F, 16CM, 3L

    Model
    • ECVC2745
    UDI-DI
    • 10653160334224
    Lot code
    • 2025091190
  23. Central Line Bundle W/7F, 20CM, 3L

    Model
    • ECVC2750
    UDI-DI
    • 10653160334217
    Lot code
    • 2025102490
    • 2025091090
  24. Central Line Insertion Bundle

    Model
    • ECVC2080
    UDI-DI
    • 10653160334408
    Lot code
    • 2025101690
  25. Chest Tube Insertion Tray

    Model
    • MNS3390
    UDI-DI
    • 00653160100433
    Lot code
    • 2025120590
    • 2025102790
    • 2025091590
  26. Circumcision Tray

    Model
    • CIT6325
    UDI-DI
    • 10653160294160
    Lot code
    • 2025102390
  27. Circumcision Tray W/1.1CM Circlamp

    Model
    • CIT3225A
    UDI-DI
    • 00653160165142
    Lot code
    • 2025102190
  28. Cont. 20G EPI MRI Compatible

    Model
    • PAIN1470A
    UDI-DI
    • 10193489957365
    Lot code
    • 25JLA514
  29. Continuous Epidural Tray

    1. Model
      • PAIN1317
      UDI-DI
      • 10888277797109
      Lot code
      • 25JLA788
    2. Model
      • PAIN1579A
      UDI-DI
      • 10193489422443
      Lot code
      • 25JLA779
    3. Model
      • PAIN2305
      UDI-DI
      • 10198459478819
      Lot code
      • 25JLA601
  30. Contraceptive Implant Insertion Kit

    Model
    • MNS9715
    UDI-DI
    • 10653160292029
    Lot code
    • 2025120890
  31. CSE Tray

    Model
    • PAIN1885A
    UDI-DI
    • 10195327486310
    Lot code
    • 25JLA861
  32. CSE Tray Medline

    Model
    • PAIN2334
    UDI-DI
    • 10198459540639
    Lot code
    • 25JLA942
  33. CVC Bundle

    Model
    • ECVC8090
    UDI-DI
    • 10653160357667
    Lot code
    • 2025091990
  34. CVC Bundle Kit

    Model
    • ECVC1700
    UDI-DI
    • 10653160363507
    Lot code
    • 2025112590
  35. CVC Bundle Triple Lumen 16CM

    Model
    • ECVC5540A
    UDI-DI
    • 10653160335009
    Lot code
    • 2025092990
  36. CVC Insertion Bundle

    Model
    • ECVC1120
    UDI-DI
    • 10653160334644
    Lot code
    • 2025091990
  37. CVC Insertion Bundle 3L 7FR 20CM

    Model
    • ECVC5610
    UDI-DI
    • 10653160335047
    Lot code
    • 2025122290
  38. CVC Insertion Bundle 8.5FR 4L 16CM

    Model
    • ECVC6355
    UDI-DI
    • 10653160336396
    Lot code
    • 2025120890
    • 2025100890
  39. CVC Insertion Kit 3L-16CM

    Model
    • ECVC8616
    UDI-DI
    • 10653160386308
    Lot code
    • 2025112490
    • 2025101690
    • 2025091990
  40. CVC Triple Lumen 7FR PI 16CM Bundle

    Model
    • ECVC8360
    UDI-DI
    • 10653160370079
    Lot code
    • 2025112490
    • 2025102190
    • 2025102490
  41. Dialysis Accessory Pack W/O Catheter

    Model
    • MNS10750A
    UDI-DI
    • 10653160380771
    Lot code
    • 2025112690
  42. Dialysis Catheter Insertion Kit

    Model
    • CVI4815
    UDI-DI
    • 10653160386049
    Lot code
    • 2025121890
  43. Epidural Tray

    Model
    • PAIN2278
    UDI-DI
    • 10198459376177
    Lot code
    • 25JLA886
  44. ER Suturing Tray

    Model
    • SUT9710C
    UDI-DI
    • 10653160331254
    Lot code
    • 2025103090
  45. Femoral Arterial Line Tray

    Model
    • ART660A
    UDI-DI
    • 10653160366096
    Lot code
    • 2025120990
    • 2025100790
  46. General Biopsy Tray

    Model
    • MNS5985
    UDI-DI
    • 00653160204407
    Lot code
    • 2025120590
    • 2025101690
  47. I & D Kit

    Model
    • ID1135A
    UDI-DI
    • 00653160204056
    Lot code
    • 2025120490
    • 2025101490
  48. Imaging Biopsy Tray

    Model
    • DYNDH1068
    UDI-DI
    • 10889942172122
    Lot code
    • 2025101090
  49. Incision & Drainage Tray

    Model
    • ID2060
    UDI-DI
    • 10653160310006
    Lot code
    • 2025101790
  50. Introflex 5F, 1L, TB, US, BAS

    Model
    • STCVC49US
    UDI-DI
    • 10653160347972
    Lot code
    • 2025092390
  51. Introflex 6F, 1L, TB, US

    Model
    • STCVC26US
    UDI-DI
    • 10653160343424
    Lot code
    • 2026010290
  52. Introflex 8.5FR. 1L CVC Bundle

    Model
    • CMPI851LBA
    UDI-DI
    • 10653160347453
    Lot code
    • 2025090290
  53. L&D Continuous Epidural Tray

    Model
    • PAIN1699A
    UDI-DI
    • 10195327411107
    Lot code
    • 25JLA719
  54. Laceration Tray

    1. Model
      • SUT10520
      UDI-DI
      • 10653160364672
      Lot code
      • 2025102790
    2. Model
      • SUT18660A
      UDI-DI
      • 10653160359302
      Lot code
      • 2025120890
      • 2025092690
    3. Model
      • DYNDL1351
      UDI-DI
      • 10884389278352
      Lot code
      • 2025120190
  55. Laceration Tray - Snag Free

    Model
    • SUT12265
    UDI-DI
    • 00653160130898
    Lot code
    • 2025102390
    • 2025090590
  56. Laceration Tray with Lidocaine

    Model
    • SUT10830A
    UDI-DI
    • 10653160386902
    Lot code
    • 2025102390
  57. Local Infiltration Tray

    Model
    • DYNDH1406
    UDI-DI
    • 10653160375739
    Lot code
    • 2025121090
    • 2025101790
  58. Lumbar Puncture Choice

    Model
    • DYNDH1215
    UDI-DI
    • 10889942550876
    Lot code
    • 2025092390
  59. Maximum Protection CVC Insertion Kit

    Model
    • ECVC1950
    UDI-DI
    • 10653160375753
    Lot code
    • 2025112690
  60. Mercy Medical Circumcision Tray

    Model
    • CIT6780
    UDI-DI
    • 10653160324232
    Lot code
    • 2025102790
  61. Multimed 7F 20CM 3L CVC Bundle

    Model
    • CMPM7203LBB
    UDI-DI
    • 10653160363798
    Lot code
    • 2025120290
    • 2025093090
  62. Multimed 7FR, 16CM, 3L CVC Bundle

    Model
    • STCVC03
    UDI-DI
    • 10653160365235
    Lot code
    • 2026011990
  63. Multimed 7FR, 20CM, 3L CVC Bundle

    Model
    • STCVC04
    UDI-DI
    • 10653160339342
    Lot code
    • 2025121890
    • 2025091890
  64. Multimed, 7FR, 20CM, 3L, CVC Bundle

    Model
    • ECVC5995
    UDI-DI
    • 10653160338970
    Lot code
    • 2026011990
    • 2025100790
  65. Myelogram Pack

    Model
    • P155615A
    UDI-DI
    • 10889942219889
    Lot code
    • 2025120890
    • 2025090490
  66. Myelogram Tray Choice

    Model
    • DYNDH1213
    UDI-DI
    • 10653160383864
    Lot code
    • 2025091990
  67. Myelogram-LF Safe Pack

    Model
    • P124863
    UDI-DI
    • 10889942140787
    Lot code
    • 2025102090
  68. No Cath Central Line Kit

    Model
    • CVI4880B
    UDI-DI
    • 10653160377191
    Lot code
    • 2026021190
  69. No Cath Dialysis Kit

    Model
    • ECVC8595
    UDI-DI
    • 10653160378822
    Lot code
    • 2025091890
  70. O.R. CVC Triple Lumen Bundle

    Model
    • ECVC1377
    UDI-DI
    • 10653160332152
    Lot code
    • 2025101690
    • 2025092290
  71. Ophthalmic Pack W/Lido

    Model
    • DYNJ57922A
    UDI-DI
    • 10195327556259
    Lot code
    • 25JLA852
  72. Pain MGMT/ Pref W. MED NDL

    Model
    • PAIN0072L
    UDI-DI
    • 10198459544163
    Lot code
    • 25JDB100
  73. Percutaneous Chest Tube Kit

    Model
    • CHT1825
    UDI-DI
    • 10653160385660
    Lot code
    • 2025120490
  74. PI CVC Kit 3L 7 fr 16 cm

    Model
    • ECVC8520
    UDI-DI
    • 10653160375104
    Lot code
    • 2026031790
    • 2025122290
  75. PICC Kit 5F DL PL MB

    Model
    • DYNJ70152MB
    UDI-DI
    • 10653160366157
    Lot code
    • 2025121290
  76. Plastics Suturing Set

    Model
    • SUT4065
    UDI-DI
    • 10653160385707
    Lot code
    • 2025112590
    • 2025091590
  77. PNBT Tray

    Model
    • SAMPA0147
    UDI-DI
    • 10198459552809
    Lot code
    • 25JLA928
  78. Pressure INJ. CVC Insertion Bundle

    Model
    • ECVC1720
    UDI-DI
    • 10653160365761
    Lot code
    • 2025121990
    • 2025091990
  79. Reinforced Cath Epidural Tray

    Model
    • PAIN1967A
    UDI-DI
    • 10198459241215
    Lot code
    • 25JLA659
  80. SM Radiology-Angio Pack-LF

    Model
    • DYNJ0621189X
    UDI-DI
    • 10195327638566
    Lot code
    • 25ILA890
  81. Soft Tissue Tray

    Model
    • DYNDA1954A
    UDI-DI
    • 10653160387060
    Lot code
    • 2025102390
  82. STD, Intro-Flex Introducer 6F, C

    Model
    • I550BF6C
    UDI-DI
    • 10653160339748
    Lot code
    • 2025102290
  83. STD, Intro-Flex Introducer 8.5F

    Model
    • I500BF85
    UDI-DI
    • 10653160378785
    Lot code
    • 2025120290
  84. STD, Intro-Flex Introducer 9F, C

    Model
    • I505BF9C
    UDI-DI
    • 10653160339687
    Lot code
    • 2025093090
  85. STD, VAN, 3L, 7F, 20CM, KIC

    Model
    • A3720KIC
    UDI-DI
    • 10653160376354
    Lot code
    • 2025121090
  86. Suture Set

    Model
    • SUT19665
    UDI-DI
    • 10653160288572
    Lot code
    • 2025102490
  87. Suture Tray

    1. Model
      • SUT12260
      UDI-DI
      • 00653160130942
      Lot code
      • 2026031190
      • 2025112690
      • 2025092690
    2. Model
      • SUT16080
      UDI-DI
      • 00653160225051
      Lot code
      • 2025092690
  88. Suturing Set

    1. Model
      • SUT13710
      UDI-DI
      • 00653160148527
      Lot code
      • 2025102290
    2. Model
      • SUT4155
      UDI-DI
      • 00653160008760
      Lot code
      • 2025100990
  89. Tray,con Epid,19G Reinf Opntip

    Model
    • PAIN2269
    UDI-DI
    • 10198459342004
    Lot code
    • 25JLA781
  90. Triple Lumen Bundle

    Model
    • ECVC5475
    UDI-DI
    • 10653160370406
    Lot code
    • 2025120190
    • 2025091190
  91. Triple Lumen Central Line Bundle

    Model
    • ECVC2625
    UDI-DI
    • 10653160334255
    Lot code
    • 2025121990
    • 2025091990
  92. Triple Lumen Complete Cath Kit

    Model
    • ECVC5200
    UDI-DI
    • 10653160336150
    Lot code
    • 2025101490
    • 2025090390
  93. Triple Lumen Complete Cath Kit 16CM

    Model
    • ECVC825A
    UDI-DI
    • 10653160387596
    Lot code
    • 2025120490
    • 2025101090
  94. Triple Lumen CVC 20CM Bundle W/O Suture

    Model
    • ECVC7290
    UDI-DI
    • 10653160344933
    Lot code
    • 2025101490
  95. Triple Lumen CVC Insertion Bundle

    Model
    • ECVC3810
    UDI-DI
    • 10653160336013
    Lot code
    • 2025102390
  96. Triple Lumen CVC Insertion Tray

    Model
    • ECVC1490A
    UDI-DI
    • 10653160367147
    Lot code
    • 2025120590
  97. Triple Lumen Insertion Kit W/Catheter

    Model
    • ECVC2885
    UDI-DI
    • 10653160335405
    Lot code
    • 2025092490
  98. TVS4000 Endovenous Pack

    Model
    • TVS4000L
    UDI-DI
    • 10195327223540
    Lot code
    • 25JDB583
    • 25KDA180
    • 25KDB274
  99. Ucla - Fine Needle Biopsy

    Model
    • P972300A
    UDI-DI
    • 10653160377467
    Lot code
    • 2025120490
  100. Ultra Core Biopsy Kit

    Model
    • SPEC0291B
    UDI-DI
    • 10653160382003
    Lot code
    • 2026010790
  101. Ultra Sound Tray

    Model
    • CVI190
    UDI-DI
    • 00653160001372
    Lot code
    • 2025120590
    • 2025112190
  102. Ultrasound Guided IV Securement Set

    Model
    • IVS3350
    UDI-DI
    • 10653160313045
    Lot code
    • 2025102490
  103. Umbilical Vessel Insertion Tray

    Model
    • UVT980
    UDI-DI
    • 10653160376705
    Lot code
    • 2025120990
  104. Universal Central/Art Line Insertion Kit

    Model
    • ART155A
    UDI-DI
    • 10653160316459
    Lot code
    • 2025100890
  105. Vantex 3L, 7FR, 16CM CVC Insertion BNDL

    Model
    • ECVC5370B
    UDI-DI
    • 10653160385905
    Lot code
    • 2025120990
    • 2025101490
  106. Vantex 7F 16CM 3L PI CVC Bundle

    Model
    • ECVC7485
    UDI-DI
    • 10653160372738
    Lot code
    • 2025120490
    • 2025091890
  107. Vantex 7F 16CM Triple Lumen CVC Kit

    Model
    • ECVC8380B
    UDI-DI
    • 10653160382409
    Lot code
    • 2025112590
    • 2025100990
  108. Vantex 7F 20CM 3L CVC Bundle

    Model
    • CMPV7203LBB
    UDI-DI
    • 10653160360025
    Lot code
    • 2025120190
  109. Vantex 7F 20CM 3L CVC Bundle Plus

    Model
    • CMPV7203LBPA
    UDI-DI
    • 10653160367529
    Lot code
    • 2025120490
    • 2025100190
  110. Vantex 7F 20CM Triple Lumen CVC Kit

    Model
    • ECVC8385B
    UDI-DI
    • 10653160382416
    Lot code
    • 2025112590
    • 2025100990
  111. Vantex 7FR 3L 16CM CVC Bundle W/US

    1. Model
      • ECVC8075
      UDI-DI
      • 10653160357124
      Lot code
      • 2025091090
    2. Model
      • ECVC7945
      UDI-DI
      • 10653160353966
      Lot code
      • 2025091190
  112. Vantex 7FR 3L 20CM Bundle

    Model
    • ECVC6110B
    UDI-DI
    • 10653160372691
    Lot code
    • 2025120490
  113. Vantex 7FR 3L 20CM CVC Bundle

    1. Model
      • ECVC6505
      UDI-DI
      • 10653160336327
      Lot code
      • 2025101490
    2. Model
      • ECVC8637
      UDI-DI
      • 10653160389538
      Lot code
      • 2025112690
  114. Vantex 7FR 3L 20CM CVC Bundle US

    Model
    • ECVC8320A
    UDI-DI
    • 10653160374589
    Lot code
    • 2025112590
  115. Vantex 7FR 3L 20CM CVC Bundle W/US

    Model
    • ECVC8180
    UDI-DI
    • 10653160378235
    Lot code
    • 2025121290
    • 2025112090
    • 2025091990
  116. Vantex 7FR 20CM 3L CVC Bundle

    Model
    • ECVC8632
    UDI-DI
    • 10653160390442
    Lot code
    • 2025121290
  117. Vantex 7FR, 16CM, 3L CVC Bundle

    Model
    • STCVC02
    UDI-DI
    • 10653160336822
    Lot code
    • 2025101690
  118. Vantex 8.5FR 2L 16CM CVC Bundle-US

    Model
    • ECVC8110
    UDI-DI
    • 10653160377207
    Lot code
    • 2025120890
    • 2025090290
  119. Vantex 8.5FR 16CM 4L CVC Bundle

    Model
    • ECVC8633
    UDI-DI
    • 10653160390428
    Lot code
    • 2025120490
    • 2025110690
  120. Vantex CVC Bundle, 7 fr 3L 16CM

    Model
    • ECVC5080
    UDI-DI
    • 10653160363194
    Lot code
    • 2025120190
  121. Vantex PI CVC 7F, 3L, 16CM Bundle

    Model
    • ECVC6920A
    UDI-DI
    • 10653160389392
    Lot code
    • 2025120890
    • 2025091190
  122. Vascular Access Insertion Kit

    Model
    • CVI5331
    UDI-DI
    • 10653160383017
    Lot code
    • 2025120390
  123. Waterbury 3L CVC Bundle

    Model
    • ECVC7330
    UDI-DI
    • 10653160364566
    Lot code
    • 2026010790

Recall details

Company began the recall
Sold in

US Nationwide distribution.

Company
Medline Industries, LPNorthfield, Illinois
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99162
Recall numbers
Z-2533-2026 to Z-2547-2026

All recalls from Medline Industries, LP

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)