Recalls affecting Hawaii

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 #:

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: 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 #:

81972

Lot/product code:

All Lots

Recalling firm:

Intuitive Surgical, Inc.

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 #:

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:

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:

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)

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:

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:

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)

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-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

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

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

Recall #:

83254

Lot/product code:

Revolution CT

Recalling firm:

GE Healthcare, LLC

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX2, model # 11284500 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX3, model # 11235411 containing the following software version: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX3, model # 11235612 containing the following software version: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B;

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

83398

Lot/product code:

All product lots of the Acuson NX2, model # 11284381 containing the following software: VA10A, VA10B,VA10C, VA11A, VA11B, VA11C

Recalling firm:

Siemens Medical Solutions USA, Inc.

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

Recall #:

82988

Lot/product code:

TASE 500

Recalling firm:

COLLINS AEROSPACE

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

Recall #:

82988

Lot/product code:

TASE 400

Recalling firm:

COLLINS AEROSPACE