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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

B. Braun IV Administration Sets Recalled for Medication Backflow and Occlusion

Agency Publication Date: November 26, 2025
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Summary

B. Braun Medical Inc. has recalled approximately 93,637,192 IV administration and extension sets due to a defect that can cause medication to flow backward from secondary (piggyback) containers into primary containers. Additionally, some sets may be impossible to prime, which is known as an occlusion. These devices are used for gravity-fed administration and with specific B. Braun infusion pumps including the Infusomat Space, Outlook, and Vista Basic models. The recall affects a vast array of sets across the ADDitIV, Anesthesia, Blood, Burette, CARESAFE, Caresite, Extension, Infusomat, SafeDAY, and SAFELINE product lines. Consumers should immediately stop using affected sets and contact the manufacturer to arrange for correction or replacement.

Risk

The defect can allow medications to flow in the wrong direction or block the flow entirely, potentially causing patients to receive the incorrect dose of medication or experience an interruption in critical therapy. This can lead to serious health complications or a lack of necessary treatment for patients in clinical and hospital settings.

What You Should Do

  1. This recall affects over 100 specific models of B. Braun IV administration and extension sets, including ADDitIV, Caresite, Infusomat, Outlook, SafeDAY, and SAFELINE branded products.
  2. Check the catalog number and UDI-DI printed on the product label or packaging to determine if your specific set is included in this recall. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled IV administration and extension sets immediately.
  4. Contact B. Braun Medical Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected devices.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding medical device recalls.

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: ADDitIV Primary Gravity IV Set
Model / REF:
V1443
V1447
V1448
V1484
UDI:
04046964188350
04046964188411
04046964188435
04046964188473

Recall #: Z-0603-2026; Quantity: 43,900 units.

Product: ADDitIV Univ IV Set with 0.2 Micron Filter
Model / REF:
352447
UDI:
04046964181665

Recall #: Z-0604-2026; Quantity: 100 units.

Product: ADDitIV Non-Vent Set 103-IN-DR
Model / REF:
352062
UDI:
04046964181160

Recall #: Z-0605-2026; Quantity: 12,700 units.

Product: Anesthesia IV Set (108 in. or 137 in.)
Model / REF:
490189
490226
UDI:
04046964303586
04046964304262

Recall #: Z-0606-2026; Quantity: 32,436 units.

Product: Anesthesia IV Set (132 in.)
Model / REF:
490469
490470
UDI:
04046964958816
04046964958830

Recall #: Z-0607-2026; Quantity: 104,784 units.

Product: Anesthesia IV Set with Extension Set
Model / REF:
490467
UDI:
04046964958779

Recall #: Z-0608-2026; Quantity: 14,712 units.

Product: Anesthesia IV Set (134 in.)
Model / REF:
490477
UDI:
04046964991271

Recall #: Z-0609-2026; Quantity: 36,552 units.

Product: Anesthesia IV Set (144 in.)
Model / REF:
490472
UDI:
04046964958878

Recall #: Z-0610-2026; Quantity: 10,536 units.

Product: Anesthesia IV Set (125 in.)
Model / REF:
490452
UDI:
04046964848933

Recall #: Z-0611-2026; Quantity: 19,392 units.

Product: Anesthesia IV Set (126 in.)
Model / REF:
490444
UDI:
04046964848773

Recall #: Z-0612-2026; Quantity: 88,200 units.

Product: Anesthesia IV Set (124 in. with Stopcocks)
Model / REF:
490476
UDI:
04046964958953

Recall #: Z-0613-2026; Quantity: 19,320 units.

Product: Anesthesia IV Set (117 in.)
Model / REF:
490468
UDI:
04046964958793

Recall #: Z-0614-2026; Quantity: 58,752 units.

Product: B. Braun IV Admin Set (141 in.)
Model / REF:
490349
UDI:
04046964602405

Recall #: Z-0615-2026; Quantity: 24,648 units.

Product: Y-Type Blood Administration Set (124 in.)
Model / REF:
490196
UDI:
04046964303722

Recall #: Z-0616-2026; Quantity: 7,344 units.

Product: Y-Type Blood Set with 170 Micron Filter (120 in.)
Model / REF:
490355
UDI:
04046964616013

Recall #: Z-0617-2026; Quantity: 24,624 units.

Product: Y-Type Blood Set (146 in.)
Model / REF:
490530
UDI:
04046955203321

Recall #: Z-0618-2026; Quantity: 33,528 units.

Product: Y-Type Blood Set with Hand Pump (146 in.)
Model / REF:
490438
UDI:
04046964833441

Recall #: Z-0619-2026; Quantity: 164,568 units.

Product: Y-Type Blood Set with 170 Micron Filter
Model / REF:
480233
UDI:
04046955083572

Recall #: Z-0620-2026; Quantity: 5,448 units.

Product: Burette Set (125 in.)
Model / REF:
490252
UDI:
04046955545636

Recall #: Z-0621-2026; Quantity: 12,320 units.

Product: Burette Set (134 in.)
Model / REF:
490159
UDI:
04046964303128

Recall #: Z-0622-2026; Quantity: 7,240 units.

Product: CARESAFE IV Administration Sets
Model / REF:
354302
354303
354304
354305
354306
354307
354308
354310
UDI:
04046955259946
04046955052424
04046955259960
04046955052448
04046955259984
04046955052462
04046955260003
04046955052929

Recall #: Z-0623-2026; Quantity: 4,438 units.

Product: Caresite Primary Gravity IV Sets
Model / REF:
354204
354205
354206
UDI:
04046964182075
04046964182099
04046964182112

Recall #: Z-0624-2026; Quantity: 12,225,913 units.

Product: Caresite Injection Site Gravity Sets
Model / REF:
354202
354203
UDI:
04046964182037
04046964182051

Recall #: Z-0625-2026; Quantity: 2,871,707 units.

Product: Caresite Primary Gravity Filtered Set
Model / REF:
354207
UDI:
04046964182136

Recall #: Z-0626-2026; Quantity: 381,850 units.

Product: Extension Set AS152V2DLL
Model / REF:
473309
UDI:
04046964299636

Recall #: Z-0627-2026; Quantity: 11,650 units.

Product: Extension Set with Ultra Y Site
Model / REF:
474912
UDI:
04046964300615

Recall #: Z-0628-2026; Quantity: 30,250 units.

Product: Anesthesia Extension Set with Safeport Manifold
Model / REF:
456520
UDI:
04046964296697

Recall #: Z-0629-2026; Quantity: 2,100 units.

Product: Extension Sets (Various Lengths)
Model / REF:
490448
490465
490486
490577
UDI:
04046964848858
04046964950735
04046964991257
04046955287536

Recall #: Z-0630-2026; Quantity: 43,452 units.

Product: Extension Set (25 in.)
Model / REF:
490629
UDI:
04046955665051

Recall #: Z-0631-2026; Quantity: 13,128 units.

Product: Extension Set with Ultraport (57 in.)
Model / REF:
490202
UDI:
04046964303845

Recall #: Z-0632-2026; Quantity: 13,600 units.

Product: Extension Set with B/C Valve (53 in.)
Model / REF:
490358
UDI:
04046964642746

Recall #: Z-0633-2026; Quantity: 1,200 units.

Product: Extension Set with Ultraport (48 in.)
Model / REF:
490291
UDI:
04046964716768

Recall #: Z-0634-2026; Quantity: 23,650 units.

Product: Extension Set Ultraport Stopcock (37 in.)
Model / REF:
490234
UDI:
04046964716362

Recall #: Z-0635-2026; Quantity: 27,480 units.

Product: Extension Set with 6 B/C Valves (17 in.)
Model / REF:
490238
UDI:
04046964716409

Recall #: Z-0636-2026; Quantity: 11,800 units.

Product: Anesthesia Set with Safeport Manifold
Model / REF:
456521
456522
UDI:
04046964296710
04046964296734

Recall #: Z-0637-2026; Quantity: 61,423 units.

Product: Caresite Extension Set (Export)
Model / REF:
470183
UDI:
04046964719400

Recall #: Z-0638-2026; Quantity: 32,500 units.

Product: Extension Set (34 in.)
Model / REF:
V5405
UDI:
04046964188978

Recall #: Z-0639-2026; Quantity: 300 units.

Product: Infusomat Infusion Pump Administration Sets
Model / REF:
362032
362033
362034
362043
362050
362420
362431
362432
363010
363019
363030
363230
363419
363420
363421
363422
363423
363424
363430
363433
480254
480255
480256
480258
480263
490100
490101
490102
490103
490104
490105
490655
UDI:
04046964182556
04046964837821
04046964182570
04046964182631
04046964182655
04046955592715
04046964294013
04046964182679
04046964294174
04046964294198
04046964294259
04046964294495
04046964294570
04046964294594
04046964294617
04046964294631
04046964294655
04046964837906
04046964294679
04046964837920
04046955324798
04046955324804
04046955324811
04046955324835
04046955693931
04046964186080
04046964186103
04046964186127
04046964302107
04046964186141
04046964186165
04046955836383

Recall #: Z-0640-2026; Quantity: 49,330,370 units.

Product: IV Administration Set (134 in.)
Model / REF:
490357
UDI:
04046964644399

Recall #: Z-0641-2026; Quantity: 98,688 units.

Product: IV Administration Set (120 in. or 144 in.)
Model / REF:
490385
490401
UDI:
04046964730146
04046964761416

Recall #: Z-0642-2026; Quantity: 168,816 units.

Product: Safeline Anesthesia IV Administration Set
Model / REF:
NF1270A
UDI:
04046964187124

Recall #: Z-0643-2026; Quantity: 13,870 units.

Product: Ultrasite IV Administration Set
Model / REF:
352394
UDI:
04046964293375

Recall #: Z-0644-2026; Quantity: 1,250 units.

Product: IV Administration Set (141 in. with Caresite)
Model / REF:
490067
UDI:
04046964186042

Recall #: Z-0645-2026; Quantity: 407,800 units.

Product: Ultraport Zer0 IV Set with Caresite
Model / REF:
457506
UDI:
04046964716126

Recall #: Z-0646-2026; Quantity: 1,019 units.

Product: IV Administration Set with B/C Valves
Model / REF:
490653
UDI:
04046955836338

Recall #: Z-0647-2026; Quantity: 48 units.

Product: Anesthesia IV Set with Ultraport Stopcock
Model / REF:
354209
490392
490428
UDI:
04046964182150
04046964737367
04046964823541

Recall #: Z-0648-2026; Quantity: 89,552 units.

Product: IV Administration Set with Extension Set
Model / REF:
490208
UDI:
04046964303968

Recall #: Z-0649-2026; Quantity: 40,008 units.

Product: IV Administration Set with 9 in. Extension Set
Model / REF:
490317
UDI:
04046964525742

Recall #: Z-0650-2026; Quantity: 6,650 units.

Product: IV Set with Ultraport Zer0 Stopcock
Model / REF:
457515
UDI:
04046964716188

Recall #: Z-0651-2026; Quantity: 135,000 units.

Product: IV Administration Set with HF Stopcock
Model / REF:
490241
490298
490360
UDI:
04046964716447
04046964716829
04046964642609

Recall #: Z-0652-2026; Quantity: 66,792 units.

Product: IV Administration Set with Extension Set (81 in.)
Model / REF:
490329
UDI:
04046964541100

Recall #: Z-0653-2026; Quantity: 18,984 units.

Product: Anesthesia IV Set with Dual Ultraport Stopcocks
Model / REF:
354210
490389
UDI:
04046964182174
04046964730207

Recall #: Z-0654-2026; Quantity: 1,861,111 units.

Product: IV Administration Set with Dual Ultraport Zer0
Model / REF:
457504
UDI:
04046964716089

Recall #: Z-0655-2026; Quantity: 80,650 units.

Product: IV Administration Set (126 in.)
Model / REF:
490283
UDI:
04046964716669

Recall #: Z-0656-2026; Quantity: 65,904 units.

Product: IV Administration Set (124 in. with Caresite)
Model / REF:
490427
UDI:
04046964823527

Recall #: Z-0657-2026; Quantity: 224,856 units.

Product: IV Administration Set (124 in.)
Model / REF:
470005
UDI:
04046964297199

Recall #: Z-0658-2026; Quantity: 29,900 units.

Product: IV Administration Set (Various Lengths)
Model / REF:
490242
490311
490353
UDI:
04046964716461
04046964539688
04046964602368

Recall #: Z-0659-2026; Quantity: 129,480 units.

Product: IV Administration Set with Triple Manifold
Model / REF:
490343
UDI:
04046964593659

Recall #: Z-0660-2026; Quantity: 1,272 units.

Product: IV Administration Set with Dual Caresite
Model / REF:
490309
UDI:
04046964527517

Recall #: Z-0661-2026; Quantity: 259,392 units.

Product: IV Administration Set (147 in.)
Model / REF:
490367
UDI:
04046964669903

Recall #: Z-0662-2026; Quantity: 6,768 units.

Product: IV Administration Set with Caresite Extension
Model / REF:
490400
UDI:
04046964761393

Recall #: Z-0663-2026; Quantity: 19,104 units.

Product: IV Administration Set (Various Branded Components)
Model / REF:
490315
490331
490376
UDI:
04046964527173
04046964541148
04046964718182

Recall #: Z-0664-2026; Quantity: 11,832 units.

Product: IV Administration Set with 9 in. Extension Set (92 in.)
Model / REF:
490489
UDI:
04046955086894

Recall #: Z-0665-2026; Quantity: 3,120 units.

Product: IV Administration Set (125 in.)
Model / REF:
490487
UDI:
04046955086856

Recall #: Z-0666-2026; Quantity: 23,160 units.

Product: IV Administration Set (162 in.)
Model / REF:
490484
UDI:
04046964991219

Recall #: Z-0667-2026; Quantity: 37,656 units.

Product: IV Administration Set (108 in.)
Model / REF:
490504
UDI:
04046955135738

Recall #: Z-0668-2026; Quantity: 36,936 units.

Product: IV Administration Set with Various Extensions
Model / REF:
490528
490550
490605
490616
490654
UDI:
04046955203284
04046955270347
04046955352876
04046955664696
04046955836369

Recall #: Z-0669-2026; Quantity: 190,625 units.

Product: SafeDAY and IV Administration Sets (Multi-Catalog)
Model / REF:
352636
352639
352640
352643
477003
477006
477008
477012
477019
477021
477022
477023
477053
490513
490521
490527
490529
490535
490543
490546
490547
490552
490553
490554
490555
490558
490559
490560
490561
490562
490563
490569
490573
490574
490575
490578
490581
490582
490583
490588
490589
490600
490607
490608
490615
490618
490619
490644
490657
490658
UDI:
04046955594597
04046955594672
04046955594696
04046955594757
04046955202836
04046955202751
04046955202850
04046955202874
04046955203147
04046955269983
04046955270002
04046955270026
04046955672431
04046955137237
04046955185252
04046955203222
04046955203307
04046955203406
04046955270200
04046955270262
04046955270286
04046955275342
04046955275366
04046955275380
04046955275403
04046955275465
04046955275489
04046955275502
04046955275526
04046955275540
04046955275564
04046955275687
04046955287451
04046955287475
04046955287499
04046955287550
04046955287611
04046955287635
04046955287659
04046955287758
04046955287772
04046955352777
04046955352913
04046955352937
04046955664672
04046955664733
04046955664757
04046955765003
04046955836420
04046955836697

Recall #: Z-0670-2026; Quantity: 20,694,734 units.

Product: IV Administration Set (99 in.)
Model / REF:
490511
UDI:
04046955135875

Recall #: Z-0671-2026; Quantity: 12,168 units.

Product: IV Administration Set (132 in.)
Model / REF:
490519
UDI:
04046955185238

Recall #: Z-0672-2026; Quantity: 1,080 units.

Product: IV Administration Set with 9 in. Extension Set (115 in.)
Model / REF:
490522
490568
UDI:
04046955203123
04046955275663

Recall #: Z-0673-2026; Quantity: 41,016 units.

Product: IV Administration Set with 15 Drops/mL
Model / REF:
490507
UDI:
04046955135790

Recall #: Z-0674-2026; Quantity: 48,672 units.

Product: IV Administration Set (Catalog 490549 & 490565)
Model / REF:
490549
490565
UDI:
04046955270323
04046955275601

Recall #: Z-0675-2026; Quantity: 65,232 units.

Product: IV Administration Set (133 in.)
Model / REF:
490245
UDI:
04046964716508

Recall #: Z-0676-2026; Quantity: 40,992 units.

Product: IV Set with Safeline and Stopcock (131 in.)
Model / REF:
490612
UDI:
04046955664610

Recall #: Z-0677-2026; Quantity: 5,952 units.

Product: IV Administration Set with Dual Caresite (153 in.)
Model / REF:
490542
UDI:
04046955270187

Recall #: Z-0678-2026; Quantity: 7,008 units.

Product: PB1500 IV Set with Dual Stopcocks
Model / REF:
490025
UDI:
04046964301056

Recall #: Z-0679-2026; Quantity: 15,250 units.

Product: NF1503 15 DR Univ Spike IV Set
Model / REF:
490062
UDI:
04046964301445

Recall #: Z-0680-2026; Quantity: 12,200 units.

Product: IV Administration Set (138 in.)
Model / REF:
490426
UDI:
04046964823503

Recall #: Z-0681-2026; Quantity: 63,192 units.

Product: IV Administration Set (Various Models 126 in. to 139 in.)
Model / REF:
490488
490492
490503
UDI:
04046955086870
04046955086757
04046955135714

Recall #: Z-0682-2026; Quantity: 187,464 units.

Product: IV Administration Set with 3 Caresite N/C Dual
Model / REF:
354211
UDI:
04046964182198

Recall #: Z-0683-2026; Quantity: 286,400 units.

Product: IV Administration Set with Safeport Manifold
Model / REF:
354208
UDI:
04046964293818

Recall #: Z-0684-2026; Quantity: 126,050 units.

Product: IV Administration Set (120 in. or 134 in.)
Model / REF:
490312
490432
UDI:
04046964525643
04046964832826

Recall #: Z-0685-2026; Quantity: 226,632 units.

Product: IV Administration Set (138 in.)
Model / REF:
490491
UDI:
04046955086931

Recall #: Z-0686-2026; Quantity: 960 units.

Product: IV Administration Set with Caresite Extension
Model / REF:
490407
UDI:
04046964773242

Recall #: Z-0687-2026; Quantity: 10,896 units.

Product: IV Administration Set with B/C Valve (103 in.)
Model / REF:
470179
UDI:
04046964773181

Recall #: Z-0688-2026; Quantity: 28,344 units.

Product: IV Administration Set with Quad Manifold (120 in.)
Model / REF:
490340
UDI:
04046964590481

Recall #: Z-0689-2026; Quantity: 25,728 units.

Product: IV Administration Set (137 in. with 3 Caresite)
Model / REF:
490303
UDI:
04046964526381

Recall #: Z-0690-2026; Quantity: 32,304 units.

Product: IV Administration Set (125 in. with 2 Caresite)
Model / REF:
490408
UDI:
04046964773266

Recall #: Z-0691-2026; Quantity: 24,072 units.

Product: IV Administration Set with 9 in. Extension (130 in.)
Model / REF:
490412
UDI:
04046964797989

Recall #: Z-0692-2026; Quantity: 45,288 units.

Product: IV Administration Set (115 in.)
Model / REF:
490354
UDI:
04046964602382

Recall #: Z-0693-2026; Quantity: 41,976 units.

Product: IV Administration Set (124 in.)
Model / REF:
490451
UDI:
04046964848919

Recall #: Z-0694-2026; Quantity: 2,544 units.

Product: IV Administration Set with HF Stopcock (Various)
Model / REF:
490193
490326
UDI:
04046964303661
04046964541063

Recall #: Z-0695-2026; Quantity: 111,312 units.

Product: IV Administration Set (118 in.)
Model / REF:
490437
UDI:
04046964833427

Recall #: Z-0696-2026; Quantity: 4,536 units.

Product: IV Administration Set (128 in.)
Model / REF:
480231
UDI:
04046955083534

Recall #: Z-0697-2026; Quantity: 85,176 units.

Product: IV Administration Set (131 in.)
Model / REF:
490274
UDI:
04046964716621

Recall #: Z-0698-2026; Quantity: 98,568 units.

Product: IV Administration Set (103 in.)
Model / REF:
490239
UDI:
04046964716423

Recall #: Z-0699-2026; Quantity: 5,100 units.

Product: NF1505 and Safeline IV Sets
Model / REF:
490088
490107
UDI:
04046964301889
04046964302145

Recall #: Z-0700-2026; Quantity: 5.900 units.

Product: NF1500UP IV Administration Set
Model / REF:
490070
UDI:
04046964301582

Recall #: Z-0701-2026; Quantity: 9,500 units.

Product: IV Administration Set (85 in. or 130 in.)
Model / REF:
477002
477017
UDI:
04046955202713
04046955203109

Recall #: Z-0702-2026; Quantity: 22,928 units.

Product: IV Administration Set with 9 in. Extension (128 in.)
Model / REF:
490301
UDI:
04046964716867

Recall #: Z-0703-2026; Quantity: 31,392 units.

Product: IV Administration Set (129 in.)
Model / REF:
490225
UDI:
04046964304248

Recall #: Z-0704-2026; Quantity: 122,232 units.

Product: Anesthesia IV Set (127 in.)
Model / REF:
490551
UDI:
04046955275304

Recall #: Z-0705-2026; Quantity: 4,488 units.

Product: Outlook Pump Set (115 in.)
Model / REF:
490361
UDI:
04046964642623

Recall #: Z-0706-2026; Quantity: 6,672 units.

Product: Outlook IV Set with 3 Caresite
Model / REF:
354213
UDI:
04046964182211

Recall #: Z-0707-2026; Quantity: 18,072 units.

Product: Outlook Pump Set (133 in.)
Model / REF:
490564
UDI:
04046955275588

Recall #: Z-0708-2026; Quantity: 2,352 units.

Product: Outlook IV Set with 2 Caresite
Model / REF:
354212
UDI:
04046964293832

Recall #: Z-0709-2026; Quantity: 162,648 units.

Product: Rateflow Admin Set with 2 Caresite
Model / REF:
375258
UDI:
04046955256976

Recall #: Z-0710-2026; Quantity: 150,664 units.

Product: SafeDAY IV Admin Set (60 Drop)
Model / REF:
352635
UDI:
04046955594948

Recall #: Z-0711-2026; Quantity: 200,917 units.

Product: SafeDAY IV Admin Set with Stopcock
Model / REF:
352646
UDI:
04046955626946

Recall #: Z-0712-2026; Quantity: 554,015 units.

Product: Safeline Universal and Additive Sets
Model / REF:
352604
NF1251
NF1290
UDI:
04046964181870
04046964187100
04046964187148

Recall #: Z-0713-2026; Quantity: 46,250 units.

Product: Ultrasite IV Administration Set
Model / REF:
352049-C
375100-C
UDI:
04046964717666
04046964717680

Recall #: Z-0714-2026; Quantity: 41,400 units.

Product: Vista Basic Pump IV Set
Model / REF:
US9923F
UDI:
04046964838156

Recall #: Z-0715-2026; Quantity: 74,652 units.

Product: Outlook IV Set with Caresite Filter
Model / REF:
354214
UDI:
04046964182235

Recall #: Z-0716-2026; Quantity: 0 units.

Product: IV Administration Set with 15 Drops/mL (Generic)
Model / REF:
490508
UDI:
04046955135813

Recall #: Z-0717-2026; Quantity: 0 units.

Product: IV Administration Set (110 in.)
Model / REF:
490566
UDI:
04046955275625

Recall #: Z-0718-2026; Quantity: 0 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97816
Status: Active
Manufacturer: B Braun Medical Inc
Sold By: B. Braun Medical Inc.; Authorized Medical Device Distributors
Manufactured In: United States
Units Affected: 116 products (43,900 units; 100 units; 12,700 units; 32,436 units; 104,784 units; 14,712 units; 36,552 units; 10,536 units; 19,392 units; 88,200 units; 19,320 units; 58,752 units; 24,648 units; 7,344 units; 24,624 units; 33,528 units; 164,568 units; 5,448 units; 12,320 units; 7,240 units; 4,438 units; 12,225,913 units; 2,871,707 units; 381,850 units; 11,650 units; 30,250 units; 2,100 units; 43,452 units; 13,128 units; 13,600 units; 1,200 units; 23,650 units; 27,480 units; 11,800 units; 61,423 units; 32,500 units; 300 units; 49,330,370; 98,688 units; 168,816 units; 13,870 units; 1,250 units; 407,800 units; 1,019 units; 48 units; 89,552 units; 40,008 units; 6,650 units; 135,000 units; 66,792 units; 18,984 units; 1,861,111 units; 80,650 units; 65,904 units; 224,856 units; 29,900 units; 129,480 units; 1,272 units; 259,392 units; 6,768 units; 19,104 units; 11,832 units; 3,120 units; 23,160 units; 37,656 units; 36,936 units; 190,625 units; 20,694,734 units; 12,168 units; 1,080 units; 41,016 units; 48,672 units; 65,232 units; 40,992 units; 5,952 units; 7,008 units; 15,250 units; 12,200 units; 63,192 units; 187,464 units; 286,400 units; 126,050 units; 226,632 units; 960 units; 10,896 units; 28,344 units; 25,728 units; 32,304 units; 24,072 units; 45,288 units; 41,976 units; 2,544 units; 111,312 units; 4,536 units; 85,176 units; 98,568 units; 5,100 units; 5.900 units; 9,500 units; 22,928 units; 31,392 units; 122,232 units; 4,488 units; 6,672 units; 18,072 untis; 2,352 units; 162,648 untis; 150,664 units; 200,917 units; 554,015 units; 46,250 units; 41,400 units; 74,652 units; 0; 0; 0)
Distributed To: Nationwide

Were You Affected by This Recall?

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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.