Recalls affecting U.S. Virgin Islands

FDA has not published a risk classification for this recall yet.

Recall #:

81957

Lot/product code:

US91412044 USO1513631

Recalling firm:

Philips North America, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

81957

Lot/product code:

CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096 CN11510097 CN11510098 CN11630118 CN11630119 CN11630120 CN11630121 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630127 CN11630128 CN11630129 CN11630130 CN11630131 CN11630137 CN11630139 CN11630140 CN11630141 CN11630142 CN11630149 CN11630150 CN11630151 CN11630152 CN11630153 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630161 CN11630162 CN11630163 CN11630164 CN11630165 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11731415 CN11731422 CN11731423 CN11731424 CN11731425 CN11731426 CN11731427 CN11731428 CN11731429 CN11731430 CN11731431 CN11731432 CN11731433 CN11731434 CN11731435 CN11731436 CN11731437 CN11731438 CN11731439 CN11731440 CN11731441 CN11731442 CN11731443 CN11731444 CN11731445 CN11731446 CN11731447 CN11731448 CN11731449 CN11731450 CN11731452 CN11731453 CN11731454 CN11731455 CN11731456 CN11731457 CN11731463 CN11731464 CN11731465 CN11731466 CN11731467 CN11731468 CN11731469 CN11832357 CN11832358 CN11832359 CN11832360 CN11832361 CN11832362 CN11832363 CN11832368 CN11832369 CN11832370 CN11832371 CN11832372 CN11832373 CN11832378 CN11832379 CN11832380 CN11832381 CN11832382 CN11832383 CN11832384 CN11832385 CN11832386 CN11832387 CN11832388 CN11832389 CN11832390 CN11832391 CN11832392 CN11832393 CN11832394 CN11832395 CN11832396 CN11832397 CN11832398 CN11832399 CN11832405 CN11832406 CN11832407 CN11832408 CN11832409 CN11832410 CN11832411 CN11832412 CN11832413 CN11832414 CN11832415 CN11832416 CN11832417 CN11832418 CN11832419 CN11832420 CN11832421 CN11832422 CN11832423 CN11832424 CN11832425 CN11832426 CN11832427 CN11832428 CN11832429 CN11832430 CN11832431 CN11832432 CN11832434 CN11832435 CN11832436 CN11832437 CN11832438 CN11832439 CN11832440 CN11832441 CN11832442 CN11832443 CN11832444 CN11832445 CN11832446 CN11832447 CN11832448 CN11832449 CN11832450 CN11832451 CN11832452 CN11832453 CN11832454 CN21102482 CN21102483 CN21102484 CN21102485 CN21102486 CN21102487 CN21204898 CN21204899 CN21204902 CN21204903 CN21204904 CN21204905 CN21204913 CN21204914 CN21204915 CN21204916 CN21204917 CN21204918 CN21204919 CN21204920 CN21204921 CN21204922 CN21204923 CN21204924 CN21204925 CN21204926 CN21204927 CN21204928 CN21204929 CN21204930 CN21204931 CN21204932 CN21204933 CN21204934 CN21204935 CN21204936 CN21204937 CN21204938 CN21204939 CN21204940 CN21204941 CN21204942 CN21204943 CN21204944 CN21204945 CN21204946 CN21204947 CN21205039 CN21205068 CN21205069 CN21205070 CN21205071 CN21205072 CN21205073 CN21205074 CN21205075 CN21205076 CN21205077 CN21205078 CN21205079 CN21205080 CN21205081 CN21205082 CN21205083 CN21205093 CN21205094 CN21306944 CN21306947 CN21306948 CN21306949 CN21306950 CN21306951 CN21408619 CN21408620 CN21510155 CN21510156 CN21510157 CN21510158 CN21510159 CN21510160 CN21510161 CN21510162 CN21510163 CN21510164 CN21510165 CN21510166 CN21510167 CN21510168 CN21510169 CN21510170 CN21510171 CN21510172 CN21510173 CN21510174 CN21510206 CN21510207 CN21510208 CN21510209 CN21510210 CN21510211 CN21510212 CN21510213 CN21510214 CN21510215 CN21510216 CN21510217 CN21510218 CN21510221 CN21510232 CN21510233 CN21510234 CN21510235 CN21510236 CN21510237 CN21510238 CN21510239 CN21510240 CN21510241 CN21510242 CN21510243 CN21510244 CN21510245 CN21510246 CN21510247 CN21510248 CN21510249 CN21510327 CN21510328 CN21510329 CN21510330 CN21510331 CN21510332 CN21510333 CN21510334 CN21510335 CN21510336 CN21510337 CN21510338 CN21510341 CN21510342 CN21510343 CN21510344 CN21510345 CN21510346 CN21510347 CN21510348 CN21510349 CN21510350 CN21510351 CN21510352 CN21510353 CN21510354 CN21510355 CN21510356 CN21510357 CN21510358 CN21510359 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630269 CN21630272 CN21630273 CN21630274 CN21630275 CN2163… (truncated, 145628 characters total — see the official FDA record for the full value)

Recalling firm:

Philips North America, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

82039

Lot/product code:

Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048

Recalling firm:

ConvaTec, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

81957

Lot/product code:

US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461

Recalling firm:

Philips North America, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

82039

Lot/product code:

Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349

Recalling firm:

ConvaTec, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

82039

Lot/product code:

Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969

Recalling firm:

ConvaTec, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI:  (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

FDA has not published a risk classification for this recall yet.

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

FDA has not published a risk classification for this recall yet.

Recall #:

82920

Lot/product code:

Software version 1.4, UDI for the software is 03610520562024.

Recalling firm:

Bio-Rad Laboratories, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

82064

Lot/product code:

Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301, 1066430302 UDI: (01)06438147009343(17)190430(10)664303

Recalling firm:

PerkinElmer Life and Analytical Sciences, Wallac, OY

FDA has not published a risk classification for this recall yet.

Recall #:

81928

Lot/product code:

60850886 60850888 60850885 60850889 60850890 60876468 60760965 60887217 60887219 60887220 60934623 60887218 60934624 60930494 60934625 60972889 60972890 60972892 61014406 61014408 61014410 61014411 61050171 61050172 61078032 61078031 61097633 61139240 61139239 61139241 61139242 61184965 61184964 61184966 61184967 61204586 61204587 61259626 61259627 61259628 61259629 61288501 61369214 61369215 61369216 61369217 61425732 61425734 61425733 61495692 61517743 61495693 61531653 61531655 61704542 61531654 61704656 61713205 61713206 61713208 61713211 61713207 61713209 61713210 61713216 61713217 61713212 61713214 61713213 61713215

Recalling firm:

Edwards Lifesciences, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

81972

Lot/product code:

All Lots

Recalling firm:

Intuitive Surgical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

RELIA, Dual chamber pacemaker (VDD):  (a) Model Number RED01, GTIN: 00643169709003, All Serial Numbers  (b) Model Number REDR01, GTIN: 00643169708990, 00643169969742, All Serial Numbers  (c) Model Number REVDD01, GTIN: 00643169709010, 00643169969773, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

SENSIA, Dual chamber pacemaker (DDD):  (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

ADAPTA, Dual chamber pacemaker (DDD):  (a) Model Number ADD01, GTIN: 00643169708754, All Serial Numbers  (b) Model Number ADDR01, GTIN: 00643169708587, 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers   (c) Model Number ADDR03, GTIN: 00643169708631, 00643169708648, All Serial Numbers  (d) Model Number ADDR06, GTIN: 00643169708655, 00643169708662, All Serial Numbers  (e) Model Number ADDRL1, GTIN: 00643169518247, 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers  (f) Model Number ADDRS1, GTIN: 00643169708716, 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers   (g) Model Number ADVDD01, GTIN: 00643169708761, 00643169708778, 00643169969735, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers  (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

vitatron (implantable pulse generator):  (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

81945

Lot/product code:

ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR):  (a) Model Number ATDR01, GTIN: 00643169882911, 00763000109059, All Serial Numbers  (b) Model Number ATDRL1, GTIN: 00643169882928, 00763000109066, All Serial Numbers  (c) Model Number ATDRS1, GTIN: 00643169882935, 00763000109073, All Serial Numbers

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0409-2019

Lot/product code:

331B18009

Recalling firm:

Prinston Pharmaceutical Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0412-2019

Lot/product code:

327B18008 327B18009

Recalling firm:

Prinston Pharmaceutical Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0410-2019

Lot/product code:

325B18004

Recalling firm:

Prinston Pharmaceutical Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0413-2019

Lot/product code:

325D18004 325D18005

Recalling firm:

Prinston Pharmaceutical Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0411-2019

Lot/product code:

327A18001 327A18002

Recalling firm:

Prinston Pharmaceutical Inc

FDA has not published a risk classification for this recall yet.

Recall #:

83254

Lot/product code:

Revolution CT

Recalling firm:

GE Healthcare, LLC