Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceSmith & Nephew, Inc.Class IIRENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
The stability data does not support the product labeled with a 10-year shelf life.
- 2017-05-10FDA-DeviceBreg IncClass IIIf Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contac
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instruct
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and inst
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instruc
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and in
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instru
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instru
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBreg IncClass IIDressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and in
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 2017-05-10FDA-DeviceBard Peripheral Vascular IncClass IIMR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 m
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
- 2017-05-10FDA-DeviceRoche Diabetes Care, Inc.Class IIAccu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
- 2017-05-10FDA-DeviceBecton Dickinson & CompanyClass IIBD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
- 2017-05-10FDA-DeviceTerumo Medical CorporationClass IISurFlo IV Catheter
According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.
- 2017-05-10FDA-DeviceRichard-Allan Scientific CompanyClass IIShandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.
Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
- 2017-05-10FDA-DeviceSonesta Medical AbClass IISonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
- 2017-05-10FDA-DeviceZimmer Trabecular Metal Technology, Inc.Class IIIThe TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instru
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
- 2017-05-10FDA-DevicePEROUSE MEDICALClass IIDOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Complaints regarding broken blister.
- 2017-05-10FDA-DeviceMedtronic Inc.Class IIMiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.
- 2017-05-10FDA-DeviceNewport Medical Instruments IncClass INewport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restrict
Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
- 2017-05-03FDA-DeviceMerit Medical Systems, Inc.Class II1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
- 2017-05-03FDA-DeviceRemel IncClass IIBlood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Confirmed complaint of surface contamination of Listeria monocytogenes.
- 2017-05-03FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system,
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
- 2017-05-03FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIStryker SmartLife Large Aseptic Housing (7126-120-000)
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.
- 2017-05-03FDA-DeviceAmendia, IncClass II01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
- 2017-05-03FDA-DeviceXTANT MEDICAL INCClass II5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in
The material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.
- 2017-05-03FDA-DeviceCareFusion 303, Inc.Class IISmartSite Add-On Bag Access Device, Model No. 10013365
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
- 2017-05-03FDA-DeviceSavaria Concord Lifts, Inc.Class IIThe Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
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