Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
Figure 1: Correct Assembly: Thread shank not visible, only shoulder can be seen.
Figure 2: Incorrect Assembly: Shoulder and thread shank both are visible.
- Product Names: Giraffe OmniBed and Giraffe OmniBed CareStation
- Giraffe OmniBed: All models
- Giraffe OmniBed CareStation: 00840682116862/All models
- Lot/Serial Numbers: See full list of affected devices
What to Do
- Do not move the canopy if a high priority alarm goes off and canopy movement stops.
- Follow all user manual instructions for pre-use steps, which include checking the function of the heater doors before clinical use.
Reason for Recall
GE HealthCare and subsidiary Datex-Ohmeda Inc. are updating use instructions for the Giraffe OmniBed and Giraffe OmniBed CareStation after reports that the screw securing the warmer heater doors may not be properly tightened, causing the heater doors to become loose. If doors become loose, a High Priority alarm goes off and canopy movement stops. If users attempt to force the canopy to keep moving, the doors may become damaged and could potentially fall on the patient.
The use of affected product may cause serious adverse health consequences from even minor trauma in the neonatal patient, including deep soft tissue injuries, traumatic brain injuries, and death.
There have been no reported injuries and no reports of death.
Device Use
Giraffe OmniBed and Giraffe OmniBed CareStations are combination infant incubator and infant warmer. The device can be operated as either an incubator or as a warmer and can transition from one mode to the other on demand. It cannot be operated in both modes at the same time. Incubators and warmers provide controlled warmth for newborns (neonates) who are unable to regulate their own body temperatures. Incubators provide an enclosed, temperature-controlled environment and warmers provide controlled heat in an open environment. These devices may also be used for short periods of time to help a neonate transition from the uterus to the external environment.
Contact Information
Customers in the U.S. with questions about this recall should contact GE Healthcare Service at 1-800-437-1171 or a local service representative.
Full List of Affected Devices
HDGR52546
HDGR52736
HDGR52802
HDGR52861
HDGR52910
HDGR52958
HDGR53007
HDGR53058
HDGR53110
HDGR53185
HDGR52547
HDGR52737
HDGR52803
HDGR52862
HDGR52911
HDGR52959
HDGR53008
HDGR53059
HDGR53112
HDGR53186
HDGR52558
HDGR52739
HDGR52804
HDGR52863
HDGR52912
HDGR52960
HDGR53009
HDGR53060
HDGR53113
HDGR53187
HDGR52609
HDGR52740
HDGR52805
HDGR52864
HDGR52913
HDGR52961
HDGR53010
HDGR53061
HDGR53114
HDGR53188
HDGR52610
HDGR52741
HDGR52806
HDGR52865
HDGR52914
HDGR52962
HDGR53011
HDGR53062
HDGR53115
HDGR53189
HDGR52613
HDGR52742
HDGR52813
HDGR52866
HDGR52915
HDGR52963
HDGR53012
HDGR53063
HDGR53116
HDGR53190
HDGR52620
HDGR52743
HDGR52814
HDGR52867
HDGR52916
HDGR52964
HDGR53013
HDGR53064
HDGR53117
HDGR53191
HDGR52621
HDGR52744
HDGR52815
HDGR52868
HDGR52917
HDGR52965
HDGR53014
HDGR53065
HDGR53119
HDGR53192
HDGR52622
HDGR52745
HDGR52816
HDGR52869
HDGR52918
HDGR52966
HDGR53015
HDGR53066
HDGR53120
HDGR53193
HDGR52623
HDGR52746
HDGR52817
HDGR52870
HDGR52919
HDGR52967
HDGR53016
HDGR53067
HDGR53125
HDGR53194
HDGR52624
HDGR52747
HDGR52818
HDGR52871
HDGR52920
HDGR52968
HDGR53018
HDGR53068
HDGR53126
HDGR53195
HDGR52626
HDGR52748
HDGR52820
HDGR52872
HDGR52921
HDGR52969
HDGR53019
HDGR53069
HDGR53127
HDGR53196
HDGR52657
HDGR52749
HDGR52821
HDGR52873
HDGR52922
HDGR52970
HDGR53021
HDGR53070
HDGR53128
HDGR53197
HDGR52658
HDGR52750
HDGR52822
HDGR52874
HDGR52923
HDGR52971
HDGR53022
HDGR53071
HDGR53129
HDGR53213
HDGR52664
HDGR52751
HDGR52823
HDGR52875
HDGR52924
HDGR52972
HDGR53023
HDGR53072
HDGR53134
HDGR53214
HDGR52665
HDGR52752
HDGR52824
HDGR52876
HDGR52925
HDGR52973
HDGR53024
HDGR53073
HDGR53135
HDGR53215
HDGR52668
HDGR52753
HDGR52825
HDGR52877
HDGR52926
HDGR52974
HDGR53025
HDGR53074
HDGR53136
HDHR53216
HDGR52669
HDGR52754
HDGR52827
HDGR52878
HDGR52927
HDGR52975
HDGR53026
HDGR53075
HDGR53137
HDGR53217
HDGR52670
HDGR52755
HDGR52828
HDGR52879
HDGR52928
HDGR52976
HDGR53027
HDGR53076
HDGR53138
HDGR53219
HDGR52671
HDGR52756
HDGR52829
HDGR52880
HDGR52929
HDGR52977
HDGR53028
HDGR53077
HDGR53139
HDGR53220
HDGR52672
HDGR52757
HDGR52830
HDGR52881
HDGR52930
HDGR52978
HDGR53029
HDGR53078
HDGR53140
HDGR53221
HDGR52673
HDGR52758
HDGR52831
HDGR52882
HDGR52931
HDGR52979
HDGR53030
HDGR53079
HDGR53141
HDGR53222
HDGR52674
HDGR52759
HDGR52832
HDGR52883
HDGR52932
HDGR52980
HDGR53031
HDGR53080
HDGR53142
HDGR53223
HDGR52675
HDGR52760
HDGR52833
HDGR52884
HDGR52933
HDGR52981
HDGR53032
HDGR53081
HDGR53145
HDGR53224
HDGR52678
HDGR52761
HDGR52835
HDGR52885
HDGR52934
HDGR52982
HDGR53033
HDGR53085
HDGR53146
HDGR53225
HDGR52682
HDGR52762
HDGR52836
HDGR52886
HDGR52935
HDGR52983
HDGR53034
HDGR53086
HDGR53147
HDGR53226
HDGR52683
HDGR52763
HDGR52839
HDGR52887
HDGR52936
HDGR52984
HDGR53035
HDGR53087
HDGR53152
HDGR53231
HDGR52684
HDGR52764
HDGR52840
HDGR52888
HDGR52937
HDGR52985
HDGR53036
HDGR53088
HDGR53153
HDGR53232
HDGR52685
HDGR52765
HDGR52841
HDGR52890
HDGR52938
HDGR52986
HDGR53037
HDGR53089
HDGR53154
HDGR53235
HDGR52686
HDGR52768
HDGR52842
HDGR52891
HDGR52939
HDGR52987
HDGR53038
HDGR53090
HDGR53155
HDGR53241
HDGR52687
HDGR52769
HDGR52843
HDGR52892
HDGR52940
HDGR52988
HDGR53039
HDGR53091
HDGR53156
HDGR53242
HDGR52700
HDGR52770
HDGR52844
HDGR52893
HDGR52941
HDGR52990
HDGR53040
HDGR53092
HDGR53157
HDGR53251
HDGR52709
HDGR52771
HDGR52845
HDGR52894
HDGR52942
HDGR52991
HDGR53041
HDGR53093
HDGR53158
HDGR52714
HDGR52775
HDGR52846
HDGR52895
HDGR52943
HDGR52992
HDGR53042
HDGR53094
HDGR53159
HDGR52718
HDGR52776
HDGR52847
HDGR52896
HDGR52944
HDGR52993
HDGR53043
HDGR53095
HDGR53160
HDGR52720
HDGR52777
HDGR52848
HDGR52897
HDGR52945
HDGR52994
HDGR53044
HDGR53096
HDGR53161
HDGR52721
HDGR52778
HDGR52849
HDGR52898
HDGR52946
HDGR52995
HDGR53045
HDGR53097
HDGR53162
HDGR52723
HDGR52779
HDGR52850
HDGR52899
HDGR52947
HDGR52996
HDGR53047
HDGR53098
HDGR53163
HDGR52726
HDGR52780
HDGR52851
HDGR52900
HDGR52948
HDGR52997
HDGR53048
HDGR53099
HDGR53164
HDGR52727
HDGR52781
HDGR52852
HDGR52901
HDGR52949
HDGR52998
HDHR53049
HDGR53100
HDGR53165
HDGR52728
HDGR52782
HDGR52853
HDGR52902
HDHR52950
HDGR52999
HDGR53050
HDGR53102
HDGR53166
HDGR52729
HDGR52789
HDGR52854
HDGR52903
HDGR52951
HDGR53000
HDGR53051
HDGR53103
HDGR53167
HDGR52730
HDGR52790
HDGR52855
HDGR52904
HDGR52952
HDGR53001
HDGR53052
HDGR53104
HDGR53168
HDGR52731
HDGR52791
HDGR52856
HDGR52905
HDGR52953
HDGR53002
HDGR53053
HDGR53105
HDGR53169
HDGR52732
HDGR52792
HDGR52857
HDGR52906
HDGR52954
HDGR53003
HDGR53054
HDGR53106
HDGR53171
HDGR52733
HDGR52793
HDGR52858
HDGR52907
HDGR52955
HDGR53004
HDGR53055
HDGR53107
HDGR53175
HDGR52734
HDGR52794
HDGR52859
HDGR52908
HDGR52956
HDGR53005
HDGR53056
HDGR53108
HDGR53176
HDGR52735
HDGR52799
HDGR52860
HDGR52909
HDGR52957
HDGR53006
HDGR53057
HDGR53109
HDGR53181
HDHR52549
HDHR52708
HDHR52774
HDHR52881
HDHR53029
HDHR52551
HDHR52709
HDHR52830
HDHR52882
HDHR53030
HDHR52552
HDHR52710
HDHR52831
HDHR52883
HDHR53031
HDHR52553
HDHR52711
HDHR52832
HDHR52884
HDHR53032
HDHR52554
HDHR52720
HDHR52833
HDHR52885
HDHR53039
HDHR52555
HDHR52721
HDHR52834
HDHR52894
HDHR53040
HDHR52556
HDHR52722
HDHR52835
HDHR52900
HDHR53041
HDHR52557
HDHR52723
HDHR52836
HDHR52901
HDHR53042
HDHR52559
HDHR52724
HDHR52837
HDHR52902
HDHR53043
HDHR52561
HDHR52725
HDHR52838
HDHR52903
HDHR53044
HDHR52562
HDHR52726
HDHR52839
HDHR52904
HDHR53045
HDHR52563
HDHR52727
HDHR52840
HDHR52905
HDHR53046
HDHR52564
HDHR52728
HDHR52841
HDHR52906
HDHR53047
HDHR52565
HDHR52729
HDHR52842
HDHR52907
HDHR53048
HDHR52567
HDHR52730
HDHR52843
HDHR52908
HDHR53049
HDHR52568
HDHR52731
HDHR52844
HDHR52909
HDHR53030
HDHR52569
HDHR52732
HDHR52845
HDHR52951
HDHR52910
HDHR52572
HDHR52733
HDHR52847
HDHR52911
HDHR53052
HDHR52573
HDHR52734
HDHR52848
HDHR52912
HDHR53053
HDHR52575
HDHR52735
HDHR52849
HDHR52913
HDHR53054
HDHR52576
HDHR52736
HDHR52850
HDHR52914
HDHR53055
HDHR52577
HDHR52737
HDHR52851
HDHR52915
HDHR53059
HDHR52578
HDHR52738
HDHR52852
HDHR52926
HDHR53062
HDHR52579
HDHR52739
HDHR52853
HDHR52927
HDHR52580
HDHR52740
HDHR52854
HDHR52928
HDHR52581
HDHR52741
HDHR52855
HDHR52929
HDHR52588
HDHR52742
HDHR52857
HDHR52971
HDHR52589
HDHR52743
HDHR52858
HDHR52972
HDHR52650
HDHR52744
HDHR52859
HDHR52974
HDHR52653
HDHR52745
HDHR52860
HDHR52975
HDHR52654
HDHR52746
HDHR52861
HDHR52976
HDHR52689
HDHR52747
HDHR52862
HDHR52977
HDHR52690
HDHR52748
HDHR52863
HDHR52978
HDHR52691
HDHR52749
HDHR52864
HDHR52979
HDHR52692
HDHR52750
HDHR52865
HDHR52981
HDHR52693
HDHR52751
HDHR52866
HDHR52982
HDHR52694
HDHR52752
HDHR52867
HDHR52983
HDHR52695
HDHR52753
HDHR52868
HDHR52985
HDHR52696
HDHR52754
HDHR52869
HDHR52986
HDHR52697
HDHR52759
HDHR52870
HDHR52987
HDHR52698
HDHR52760
HDHR52871
HDHR52988
HDHR52699
HDHR52767
HDHR52872
HDHR52989
HDHR52700
HDHR52768
HDHR52873
HDHR52990
HDHR52701
HDHR52769
HDHR52874
HDHR52991
HDHR52702
HDHR52770
HDHR52875
HDHR52992
HDHR52703
HDHR52771
HDHR52876
HDHR52993
HDHR52704
HDHR52772
HDHR52877
HDHR52994
HDHR52707
HDHR52773
HDHR52880
HDHR52995
2082844-001-526493, 1TABX6226911180201 (TABX62269)
2082844-001-526493, 1TABX6215911180122 (TABX62159)
2082844-001-526493, 1TABX6219811180129 (TABX62198)
2082844-001-526493, 1TABX6227011180201 (TABX62270)
2082844-001-526493, 1TABX6229111180202 (TABX62291)
2082844-001-526493, 1TABX6215611180122 (TABX62156)
2082844-001-526493, 1TABX6226011180201 (TABX62260)
2082844-001-526493, 1TABX6213511180119 (TABX62135)
2082844-001-526493, 1TABX6218911180124 (TABX62189)
2082844-001-526493, 1TABX6219611180124 (TABX62196)
2082844-001-526493, 1TABX6218811180124 (TABX62188)
2082844-001-526493, 1TABX6216011180122 (TABX62160)
2082844-001-487119, To be provided (TABV60550)
2082844-001-526493, 1TABW6398711171213 (TABW63987)
2082844-001-526493, 1TABX6214111180119 (TABX62141)
2082844-001-526493, 1TABW6409911171219 (TABW64099)
2082844-001-526493, 1TABW6400911171213 (TABW64009)
2082844-001-526493, 1TABW6396611171211 (TABW63966)
2082844-001-526493, 1TABW6400811171213 (TABW64008)
2082844-001-526493, 1TABX6215411180122 (TABX62154)
2082844-001-526493, 1TABW6408611171219 (TABW64086)
2082844-001-526493, 1TABX6210811180117 (TABX62108)
2082844-001-526493, 1TABX6213011180119 (TABX62130)
2082844-001-526493, 1TABW6406911171219 (TABW64069)
2082844-001-526493, 1TABW6408411171219 (TABW64084)
2082844-001-526493, 1TABW6404311171218 (TABW64043)
2082844-001-526493, 1TABW6409811171219 (TABW64098)
2082844-001-526493, 1TABW6396411171211 (TABW63964)
2082844-001-526493, 1TABW6404911171218 (TABW64049)
2082844-001-526493, 1TABW6395411171211 (TABW63954)
2082844-001-526493, 1TABW6408711171219 (TABW64087)
2082844-001-487119, Not Applicable (TABV60078)
2082844-001-526493, 1TABX6232011180207 (TABX62320)
2082844-001-526493, 1TABX6227211180201 (TABX62272)
2082844-001-526493, 1TABX6211811180119 (TABX62118)
2082844-001-526493, 1TABX6214611180119 (TABX62146)
2082844-001-526493, 1TABW6398311171213 (TABW63983)
2082844-001-526493, 1TABW6399411171213 (TABW63994)
2082844-001-526493, 1TABX6220011180129 (TABX62200)
2082844-001-526493, 1TABW6396211171211 (TABW63962)
2082844-001-526493, 1TABX6227611180201 (TABX62276)
2082844-001-487119, Not Applicable (TABV60092)
2082844-001-526493, 1TABW6393811171211 (TABW63938)
2082844-001-526493, 1TABW6399511171213 (TABW63995)
2082844-001-526493, 1TABX6213111180119 (TABX62131)
2082844-001-526493, 1TABX6225711180201 (TABX62257)
2082844-001-526493, 1TABX6214011180119 (TABX62140)
2082844-001-526493, 1TABX6226411180201 (TABX62264)
2082844-001-526493, 1TABX6231911180207 (TABX62319)
2082844-001-526493, 1TABX6230111180202 (TABX62301)
2082844-001-526493, 1TABX6228711180202 (TABX62287)
2082844-001-526493, 1TABX6229611180202 (TABX62296)
2082844-001-526493, 1TABX6230011180202 (TABX62300)
2082844-001-526493, 1TABX6233311180207 (TABX62333)
2082844-001-526493, 1TABX6233111180207 (TABX62331)
2082844-001-526493, 1TABX6229011180202 (TABX62290)
2082844-001-526493, 1TABX6229311180202 (TABX62293)
2082844-001-526493, 1TABX6216311180123 (TABX62163)
2082844-001-526493, 1TABX6223511180130 (TABX62235)
2082844-001-526493, 1TABX6222711180130 (TABX62227)
2082844-001-526493, 1TABX6216811180123 (TABX62168)
2082844-001-526493, 1TABX6216411180123 (TABX62164)
2082844-001-526493, 1TABX6214911180122 (TABX62149)
2082844-001-526493, 1TABX6217811180123 (TABX62178)
2082844-001-526493, 1TABX6220611180129 (TABX62206)
2082844-001-526493, 1TABX6216511180123 (TABX62165)
2082844-001-526493, 1TABX6225011180201 (TABX62250)
2082844-001-526493, 1TABX6217311180123 (TABX62173)
2082844-001-526493, 1TABX6216211180123 (TABX62162)
2082844-001-526493, 1TABX6216611180123 (TABX62166)
2082844-001-526493, 1TABX6223411180130 (TABX62234)
2082844-001-526493, 1TABX6220811180129 (TABX62208)
2082844-001-526493, 1TABW6395211171211 (TABW63952)
2082844-001-526493, 1TABW6395111171211 (TABW63951)
2082844-001-526493, 1TABW6407811171219 (TABW64078)
2082844-001-526493, 1TABX6211011180117 (TABX62110)
2082844-001-526493, 1TABX6211311180117 (TABX62113)
2082844-001-526493, 1TABX6233211180207 (TABX62332)
2082844-001-526493, 1TABX6228211180201 (TABX62282)
2082844-001-526493, 1TABX6228311180201 (TABX62283)
2082844-001-526493, 1TABW6404611171218 (TABW64046)
2082844-001-526493, 1TABW6400011171213 (TABW64000)
2082844-001-526493, 1TABW6409511171219 (TABW64095)
2082844-001-526493, 1TABW6409611171219 (TABW64096)
2082844-001-526493, 1TABW6393311171211 (TABW63933)
2082844-001-526493, 1TABX6232411180207 (TABX62324)
2082844-001-526493, 1TABX6229211180202 (TABX62292)
2082844-001-526493, 1TABX6225411180201 (TABX62254)
2082844-001-526493, 1TABX6225511180201 (TABX62255)
2082844-001-526493, 1TABX6225811180201 (TABX62258)
2082844-001-487119, Not Applicable (TABV60433)
2082844-001-526493, 1TABX6219711180124 (TABX62197)
2082844-001-526493, 1TABX6212811180119 (TABX62128)
2082844-001-526493, 1TABW6394411171211 (TABW63944)
2082844-001-526493, 1TABW6398211171213 (TABW63982)
2082844-001-526493, 1TABW6394811171211 (TABW63948)
2082844-001-526493, 1TABW6394011171211 (TABW63940)
2082844-001-526493, 1TABX6222611180130 (TABX62226)
2082844-001-526493, 1TABW6393711171211 (TABW63937)
2082844-001-526493, 1TABX6224011180130 (TABX62240)
2082844-001-526493, 1TABX6223911180130 (TABX62239)
2082844-001-526493, 1TABW6399611171213 (TABW63996)
2082844-001-526493, 1TABX6224311180130 (TABX62243)
2082844-001-526493, 1TABX6224211180130 (TABX62242)
2082844-001-526493, 1TABX6224411180201 (TABX62244)
2082844-001-526493, 1TABX6222911180130 (TABX62229)
2082844-001-526769, 1TABW6397711171212 (TABW63977)
2082844-001-526493, 1TABW6401311171213 (TABW64013)
2082844-001-526493, 1TABW6395911171211 (TABW63959)
2082844-001-526493, 1TABW6408211171219 (TABW64082)
2082844-001-526493, 1TABW6402311171213 (TABW64023)
2082844-001-526493, 1TABW6396511171211 (TABW63965)
2082844-001-526493, 1TABX6233511180207 (TABX62335)
2082844-001-526493, 1TABX6229511180202 (TABX62295)
2082844-001-526493, 1TABX6224611180201 (TABX62246)
2082844-001-526493, 1TABX6225311180201 (TABX62253)
2082844-001-526493, 1TABX6222311180130 (TABX62223)
2082844-001-526493, 1TABX6225111180201 (TABX62251)
2082844-001-526493, 1TABX6225211180201 (TABX62252)
2082844-001-526493, 1TABX6223311180130 (TABX62233)
2082844-001-526493, 1TABX6223211180130 (TABX62232)
2082844-001-526493, 1TABX6223611180130 (TABX62236)
2082844-001-526493, 1TABX6224811180201 (TABX62248)
2082844-001-526493, 1TABX6223811180130 (TABX62238)
2082844-001-526493, 1TABX6224911180201 (TABX62249)
2082844-001-526493, 1TABX6224511180201 (TABX62245)
2082844-001-526493, 1TABX6210911180117 (TABX62109)
2082844-001-526493, 1TABX6219411180124 (TABX62194)
2082844-001-526493, 1TABX6219311180124 (TABX62193)
2082844-001-526493, 1TABX6213911180119 (TABX62139)
2082844-001-526493, 1TABX6216111180122 (TABX62161)
2082844-001-526493, 1TABX6213611180119 (TABX62136)
2082844-001-526493, 1TABX6212011180119 (TABX62120)
2082844-001-526493, 1TABX6215811180122 (TABX62158)
2082844-001-526493, 1TABX6213211180119 (TABX62132)
2082844-001-526493, 1TABX6217111180123 (TABX62171)
2082844-001-526493, 1TABX6221811180130 (TABX62218)
2082844-001-526493, 1TABW6405911171219 (TABW64059)
2082844-001-526493, 1TABX6224711180201 (TABX62247)
2082844-001-526493, 1TABX6223111180130 (TABX62231)
2082844-001-403566, Not Applicable (TABU67011)
2082844-001-499499, 1TABW6259811170606 (TABW62598)
2082844-001-430326, Not Applicable (TABV60027)
2082844-001-430326, Not Applicable (TABV60030)
2082844-001-430326, Not Applicable (TABV60028)
2082844-001-430326, Not Applicable (TABU67004)
2082844-001-462725, Not Applicable (TABU67040)
2082844-001-462725, Not Applicable (TABU67039)
2082844-001-462725, Not Applicable (TABU67056)
2082844-001-462725, Not Applicable (TABU67041)
2082844-001-462725, Not Applicable (TABU67053)
2082844-001-462725, Not Applicable (TABU67045)
2082844-001-462725, Not Applicable (TABU67047)
2082844-001-462725, Not Applicable (TABU67050)
2082844-001-462725, Not Applicable (TABU67043)
2082844-001-460023, Not Applicable (TABU67014)
2082844-001-510290, 010084068211685521TABV61236160902 (TABV61236)
2082844-001-558377, 1TABX6238011180219 (TABX62380)
2082844-001-534467, 1TABX6330711180628 (TABX63307)
2082844-001-534467, 1TABX6330611180628 (TABX63306)
2082844-001-534467, 1TABX6331411180628 (TABX63314)
2082844-001-534467, 1TABX6236011180213 (TABX62360)
2082844-001-534467, 1TABX6331211180628 (TABX63312)
2082844-001-534467, 1TABX6331111180628 (TABX63311)
2082844-001-534467, 1TABX6330911180628 (TABX63309)
2082844-001-534467, 1TABX6331511180628 (TABX63315)
2082844-001-501649, 1TABX6330411180626 (TABX63304)
2082844-001-501649, 1TABX6330311180626 (TABX63303)
2082844-001-501649, 1TABX6330511180626 (TABX63305)
2082844-001-467192, Not Applicable (TABV60033)
2082844-001-495642, Not Applicable (TABV60053)
2082844-001-508846, 1TABX6247711180301 (TABX62477)
2082844-001-508846, 1TABX6247611180301 (TABX62476)
2082844-001-508846, 1TABX6246211180228 (TABX62462)
2082844-001-508846, 1TABX6246311180228 (TABX62463)
2082844-001-508846, 1TABX6248411180305 (TABX62484)
2082844-001-508846, 1TABX6248511180305 (TABX62485)
2082844-001-498552, 1TABX6248911180305 (TABX62489)
2082844-001-498552, 1TABX6248611180305 (TABX62486)
2082844-001-498552, 1TABX6248711180305 (TABX62487)
2082844-001-498552, 1TABX6248811180305 (TABX62488)
2082844-001-508846, 1TABX6332211180629 (TABX63322)
2082844-001-508846, 1TABX6332111180629 (TABX63321)
2082844-001-508846, 1TABX6221111180130 (TABX62211)
2082844-001-508846, 1TABX6221211180130 (TABX62212)
2082844-001-485099, Not Applicable (TABV60013)
2082844-001-485099, Not Applicable (TABV60102)
2082844-001-485099, Not Applicable (TABV60055)
2082844-001-485099, Not Applicable (TABV60054)
2082844-001-485099, Not Applicable (TABV60065)
2082844-001-485099, Not Applicable (TABV60015)
2082844-001-485099, Not Applicable (TABV60072)
2082844-001-485099, Not Applicable (TABV60069)
2082844-001-485099, Not Applicable (TABV60016)
2082844-001-512022, 1TABX6332411180702 (TABX63324)
2082844-001-531627, 1TABX6254211180309 (TABX62542)
2082844-001-512022, 1TABX6254111180307 (TABX62541)
2082844-001-495786, Not Applicable (TABV60056)
2082844-001-565598, 1TABX63177180605 (TABX63177)
2082844-001-565598, 1TABX63176180605 (TABX63176)
2082844-001-565598, 1TABX63175180605 (TABX63175)
2082844-001-535110, 1TABX6332011180629 (TABX63320)
2082844-001-534358, 1TABX6237111180215 (TABX62371)
2082844-001-534358, 1TABX6266511180313 (TABX62665)
2082844-001-523533, 1TABW62153170215 (TABW62153)
2082844-001-547388, 1TABX63316180628 (TABX63316)
2082844-001-498396, 1TABX6331811180629 (TABX63318)
2082844-001-498396, 1TABX6331911180629 (TABX63319)
2082844-001-505050, 1TABX62459180227 (TABX62459)
2082844-001-505050, 1TABX62460180227 (TABX62460)
2082844-001-505050, 1TABW63210170815 (TABW63210)
2082844-001-507094, 010084068211685521TABV61052160804 (TABV61052)
2082844-001-510416, 1TABX62540180307 (TABX62540)
2082844-001-500909, 1TABX62457180227 (TABX62457)
2082844-001-500909, 1TABX62458180227 (TABX62458)
2082844-001-477964, Not Applicable (TABU67058)
2082844-001-516038, 1TABX6246111180227 (TABX62461)
2082844-001-501478, 1TABX62431180222 (TABX62431)
2082844-001-471681, Not Applicable (TABU67028)
2082844-001-471681, Not Applicable (TABU67034)
2082844-001-471681, Not Applicable (TABU67032)
2082844-001-462005, Not Applicable (TABU67021)
2082844-001-462005, Not Applicable (TABU67026)
2082844-001-516778, 1TABX6248011180302 (TABX62480)
2082844-001-516778, 1TABX6248111180302 (TABX62481)
2082844-001-516778, 1TABX6247811180302 (TABX62478)
2082844-001-516778, 1TABX6247911180302 (TABX62479)
2082844-001-516778, 1TABV6231611161114 (TABV62316)
2082844-001-500008, 1TABX62365180215 (TABX62365)
2082844-001-500008, 1TABX62363180215 (TABX62363)
2082844-001-500008, 1TABX62362180215 (TABX62362)
2082844-001-500008, 1TABX62367180215 (TABX62367)
2082844-001-500008, 1TABX62364180215 (TABX62364)
2082844-001-500008, 1TABX62366180215 (TABX62366)
2082844-001-500008, 1TABX62369180215 (TABX62369)
2082844-001-500008, 1TABX62368180215 (TABX62368)
2082844-001-500008, 010084068211685521TABV62289161114 (TABV62289)
2082844-001-500008, 010084068211685521TABV62294161114 (TABV62294)
2082844-001-499372, 1TABX62377180215 (TABX62377)
2082844-001-499372, 1TABX62376180215 (TABX62376)
2082844-001-499372, 1TABX62373180215 (TABX62373)
2082844-001-499372, 1TABX62374180215 (TABX62374)
2082844-001-517864, 1TABX63236180619 (TABX63236)
2082844-001-517864, 1TABX63252180619 (TABX63252)
2082844-001-403565, Not Applicable (TABV60039)
2082844-001-559202, 1TABX6248211180302 (TABX62482)
2082844-001-403565, Not Applicable (TABV60097)
2082844-001-403565, Not Applicable (TABV60062)
2082844-001-403565, Not Applicable (TABV60003)
2082844-001-403565, Not Applicable (TABV60060)
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.