Recalls affecting Wisconsin

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:

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:

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:

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)

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-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-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

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 # 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 #:

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 # 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 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 #:

82988

Lot/product code:

TASE 400

Recalling firm:

COLLINS AEROSPACE

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 #:

82066

Lot/product code:

Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1

Recalling firm:

Medline Industries Inc

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

Recall #:

84126

Lot/product code:

Lot numbers 1832-1099 and 1828-0982.

Recalling firm:

RHONDIUM LIMITED

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

Recall #:

81977

Lot/product code:

All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.

Recalling firm:

Moller Vital

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

Recall #:

81977

Lot/product code:

All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.

Recalling firm:

Moller Vital

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

Recall #:

82197

Lot/product code:

Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

Recalling firm:

CP Medical Inc

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

Recall #:

82014

Lot/product code:

All software versions, all serial numbers.

Recalling firm:

Draegar Medical Systems, Inc.

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

Recall #:

82014

Lot/product code:

All software versions, all serial numbers.

Recalling firm:

Draegar Medical Systems, Inc.

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

Recall #:

82982

Lot/product code:

CT 710

Recalling firm:

GE Healthcare, LLC