| Date Initiated by Firm | February 18, 2026 |
| Date Posted | March 19, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1580-2026 |
| Recall Event ID |
98426 |
| Product Classification |
Bed, pediatric open hospital - Product Code FMS
|
| Product | Cub Pediatric Crib, Model FL19H |
| Code Information |
UDI-DI (GTIN)
07613327169348
Serial Numbers
F61948
F61875
F61710
F62449
F62450
F62451
F62452
F62047
F62048
F62498
F62499
F62500
F61619
F61620
F61621
F61622
F61623
F61624
F61625
F61626
F61627
F61628
F61629
F61630
F61631
F61632
F61633
F61634
F61635
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F61639
F61640
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F61644
F61645
F61646
F61647
F61648
F61649
F61650
F61651
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F61653
F61654
F61655
F61656
F61657
F61658
F61659
F61660
F61661
F61662
F61663
F61664
F61665
F61666
F61667
F61668
F61669
F61670
F61671
F61672
F61673
F61674
F61675
F61676
F61677
F61678
F61679
F61680
F61681
F61682
F61683
F61684
F61685
F61686
F61687
F61688
F61889
F61890
F61891
F61892
F61893
F61698
F61699
F62448
F61972
F61988
F61989
F62181
F62501
F62502
F62532
F62533
F62432
F62446
F62447
F61595
F61992
F61993
F62125
F62389
F61894
F62123
F61742
F61743
F62117
F62118
F62119
F62433
F62434
F62435
F62436
F62437
F61917
F61918
F61919
F61920
F61921
F61922
F61923
F61924
F61925
F61926
F61927
F61928
F61929
F61930
F61865
F61866
F62159
F62160
F62161
F62325
F62158
F62204
F62205
F62524
F62525
F61695
F61696
F61729
F62083
F62084
F62085
F62086
F62087
F61763
F61764
F61765
F61766
F61767
F61768
F61769
F61770
F61771
F61772
F62431
F62394
F62395
F62396
F62397
F62398
F62399
F62400
F62401
F62402
F62403
F62419
F62420
F62421
F62422
F62423
F62424
F62425
F61998
F61693
F61694
F62530
F62531
F61697
F61700
F62371
F62372
F62373
F62374
F62375
F62195
F62015
F62248
F62249
F62380
F61945
F61946
F61947
F62146
F62147
F62331
F62332
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F61933
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F61575
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F61604
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F61611
F61612
F61613
F61614
F62010
F62011
F62012
F62013
F62014
F61910
F61911
F61912
F61785
F62044
F62045
F61991
F62462
F61826
F61827
F61828
F61829
F61830
F61831
F61832
F61833
F61834
F61835
F61836
F61837
F62116
F62246
F62247
F62459
F62460
F62518
F62519
F61741
F61745
F61746
F62177
F62178
F62179
F62180
F62453
F62454
F61915
F61916
F62552
F62553
F62554
F62555
F62556
F62557
F62558
F62559
F62126
F62335
F62336
F62337
F62338
F62339
F62340
F62341
F62342
F62343
F62344
F62345
F62346
F62347
F62348
F62349
F62350
F62351
F62352
F62353
F62354
F62355
F61570
F61970
F62503
F62504
F62505
F62506
F62507
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F62509
F62510
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F62513
F62514
F62515
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F62517
F62305
F62429
F62430
F62303
F62304
F62370
F61788
F61789
F61790
F61791
F61792
F61793
F61794
F61795
F61796
F61797
F62226
F62227
F61881
F61882
F61883
F61884
F61885
F61886
F61887
F61888
F62077
F61711
F61712
F61713
F61714
F62382
F62388
F61717
F61718
F61719
F61720
F61721
F61736
F61737
F61738
F61739
F61740
F62033
F61701
F61702
F61703
F61704
F61705
F61857
F61858
F61786
F61787
F62306
F62307
F62356
F62357
F62358
F62359
F62360
F62361
F61581
F61715
F61716
F62148
F62149
F62150
F62151
F62152
F62153
F61838
F61839
F61840
F61841
F61842
F61843
F61913
F61914
F62108
F62109
F62110
F62111
F62112
F62113
F62127
F62128
F62129
F62130
F62131
F62132
F62120
F62464
F62466
F62467
F62468
F62469
F62470
F62471
F62472
F62473
F62474
F61449
F61450
F62463
F62287
F62288
F62289
F62290
F62291
F62309
F62310
F62311
F62312
F62313
F62314
F62315
F62316
F62317
F62318
F62319
F62320
F62321
F62322
F62323
F62324
F62362
F62363
F62043
F62404
F62405
F62194
F62364
F62365
F62366
F62367
F61735
F61761
F61762
F61747
F61748
F61749
F61760
F62156
F62157
F61864
F61447
F61971
F62016
F62228
F62229
F62230
F62231
F62232
F61582
F61583
F61584
F61585
F62080
F62081
F62196
F62197
F62198
F62529
F62520
F62521
F62522
F62523
F61851
F61852
F61853
F61854
F61855
F61856
F61730
F61731
F61732
F61733
F62497
F61579
F61744
F61750
F61751
F61752
F61753
F61754
F61755
F61999
F62000
F62001
F62002
F62003
F62004
F62005
F62006
F62007
F62008
F61773
F61774
F61990
F62042
F62465
F62250
F62251
F62252
F62253
F62254
F62255
F62256
F62257
F62258
F62259
F62260
F62261
F62262
F62263
F62264
F62266
F62267
F62268
F62269
F62270
F62271
F62272
F62273
F62274
F62275
F62276
F62277
F62278
F62279
F62280
F62281
F62282
F62283
F62284
F62285
F62286
F62292
F62293
F62294
F62295
F62296
F62297
F62298
F62376
F62416
F62417
F61571
F61572
F61573
F61574
F62049
F62050
F62051
F62052
F62009
F62368
F62369
F61931
F61932
F62021
F62022
F62023
F61592
F61593
F62409
F61580
F61589
F61590
|
| FEI Number |
1831750
|
Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 E Centre Ave Portage MI 49002-5826
|
Manufacturer Reason for Recall | Cribs sold in the USA are missing two access door warning labels. |
FDA Determined Cause 2 | Under Investigation by firm |
| Action | On February 18. 2026, the firm notified customers through IMPORTANT MEDICAL DEVICE CORRECTION letters. Customers were notified of the missing warning labels, which read,
"WARNING: Never leave a child unsupervised when the movable slide is open or not secured
Refer to Instructions for Use for product care, maintenance, and cleaning."
Customers were instructed to locate the units listed on the attached business reply form and identify the address where they can be serviced, and return the completed form to Stryker. Stryker will then contact consignees to arrange for the application of the missing label.
In the interim, until the service can be performed, all pertinent warnings and
safety instructions may be found in the product manual: https://techweb.stryker.com/Stretcher/FL19/1607/Operations/1900-109-
001AC.0.pdf |
| Quantity in Commerce | 590 |
| Distribution | US Nationwide distribution. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|