Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIAdvanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIBoston Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00536620
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
- 2019-12-04FDA-DeviceVital Scientific N.V.Class IIV-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
- 2019-12-04FDA-DeviceSPINEART SAClass IIIIntersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Inner blister pack label is incorrect and does not match the correct external box label.
- 2019-12-04FDA-DeviceAbbott Gmbh & Co. KGClass IIAccessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
- 2019-12-04FDA-DeviceAbbott Gmbh & Co. KGClass IIAccessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
- 2019-12-04FDA-DeviceAbbott Gmbh & Co. KGClass IIAlinity ci Level Sensor, Bulk Solution
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
- 2019-12-04FDA-DeviceENDOTRONIXClass IImyCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix.
- 2019-12-04FDA-DeviceHelena Laboratories, Corp.Class IIICollagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
- 2019-12-04FDA-DeviceHelena Laboratories, Corp.Class IIIPlatelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)
Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
- 2019-12-04FDA-DeviceFoundation Medicine, Inc.Class IIFoundationOne CDx test report
Identified potential false positive MSI-H on the test reports provided to the physicians.
- 2019-12-04FDA-DeviceNextremity SolutionsClass IIStratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIBIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IILT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage:
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class II2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIBALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIGUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIHA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HA
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IICopeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIVarious Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114213 CP114388 CP114436 CP114463 CP114472 CP114478 CP114495 CP114532 CP114561 CP114563 CP114605 CP114695 CP114756 CP114782 CP114783 CP114933 CP114987 CP115008 CP115048 CP115049 CP115050 CP115166 CP115
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIComprehensive RS Cleat CAP, Item No. 110300
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIComprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIVarious Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-10
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIHENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IIACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IICOMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10)704850 (01)00880304475342(17)220128(10)094500 (01)00880304475342(17)220328(10)856620 (01)00880304475342(17)220528(10)487710 (01)00880304475342(17)220628(10)028860 (01)00880304475342(17)220628(10)028870 (01)0088030
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceZimmer Biomet, Inc.Class IICompress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, ar
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
- 2019-12-04FDA-DeviceBecton Dickinson & CompanyClass IISite~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog N
The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only
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