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-DeviceBard Peripheral Vascular IncClass IIPowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Complaints received that products packaged with the incorrect introducer sheath size.
- 2019-12-04FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH 930 Analyzer
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIRebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IINC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250,
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIGuidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIEmerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR U
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
- 2019-12-04FDA-DeviceSpectranetics CorporationClass IISpectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
The incorrect outer carton box was used for the product.
- 2019-12-04FDA-DeviceAbbott GmBH & Co. KGClass IIAlinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
- 2019-12-04FDA-DeviceAbbott Gmbh & Co. KGClass IIARCHITECT HAVAB-G Calibrator, REF 6L27-01
Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IICPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IISWANSON TRAPEZIUM IMPLANT, Part Number 4520002
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IISWANSON FINGER JOINT #2, Part Number 4700002
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IISWANSON FINGER JOINT #1, Part Number 4700001
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIEVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIDarco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIDart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIVALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIINBONE STEM, TIBIAL, TOP, Part Number 200011901
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIPRO-STIM 10cc INJECTABLE, Part Number 86SR0410
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IIORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceWright Medical Technology, Inc.Class IISWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
The firm discovered a lack of adequate documentation confirming sterility on certain products.
- 2019-12-04FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
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 15cm UPN: M005337206
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 13cm UPN: M00536710
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 12cm UPN: M00536700
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 11cm UPN: M005336690
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 10cm UPN: M005336680
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 9cm UPN: M00536670
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 8cm UPN: M00536660
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 7cm UPN: M00536650
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
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