Medical DeviceJul 8, 2015
LifeHealth recall — FDA Z-1919-2015
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Class IIFDA: TerminatedLifeHealth, LLC
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1184
29,963 detailed records are currently available in this category.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x recall — FDA Z-1888-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code recall — FDA Z-1892-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item recall — FDA Z-1902-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 1, 2015
Hill-Rom Steriseal-Cannula Ophthalmic recall — FDA Z-1820-2015
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Class IIFDA: TerminatedHill-Rom, Inc.
Medical DeviceJul 1, 2015
Stryker Sustainability Solutions Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model # recall — FDA Z-1836-2015
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Class IIFDA: TerminatedStryker Sustainability Solutions
Medical DeviceJul 1, 2015
X Spine Systems Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine recall — FDA Z-1823-2015
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Class IIFDA: TerminatedX Spine Systems Inc.
Medical DeviceJul 1, 2015
ArthroCare Medical EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA recall — FDA Z-1832-2015
Potential component failure causing device inoperability
Class IIFDA: TerminatedArthroCare Medical Corporation
Medical DeviceJul 1, 2015
Smith & Nephew ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended recall — FDA Z-1822-2015
Sterility of device maybe compromised
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceJul 1, 2015
Cook LapSac Surgical Tissue Pouch recall — FDA Z-1830-2015
Includes Information not stated in the intended use.
Class IIFDA: TerminatedCook Inc.
Medical DeviceJul 1, 2015
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture recall — FDA Z-1839-2015
Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.
Class IIFDA: TerminatedEthicon, Inc.
Medical DeviceJul 1, 2015
Volcano Prestige Plus 185cm J-Tip: Part number: 9185J recall — FDA Z-1845-2015
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the…
Class IIFDA: TerminatedVolcano Corporation
Medical DeviceJul 1, 2015
GE Healthcare recall — FDA Z-1825-2015
GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 1, 2015
Bio-Rad Laboratories The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog recall — FDA Z-1840-2015
The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Class IIIFDA: TerminatedBio-Rad Laboratories, Inc.
Medical DeviceJul 1, 2015
CooperSurgical McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose recall — FDA Z-1824-2015
Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
Class IIFDA: TerminatedCooperSurgical, Inc.
Medical DeviceJul 1, 2015
Stryker Endoscopy SERFAS 90 degree Energy Probe, Part Number 279-350-101 recall — FDA Z-1831-2015
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceJul 1, 2015
Remel VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc recall — FDA Z-1841-2015
Use of the recalled product may result in false positive reports.
Class IIFDA: TerminatedRemel Inc.
Medical DeviceJul 1, 2015
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO recall — FDA Z-1826-2015
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceJul 1, 2015
Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy recall — FDA Z-1843-2015
IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceJul 1, 2015
Varian Medical Systems Surface Applicator Set with Leipzig-style Cone recall — FDA Z-1829-2015
Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080…
Class IIFDA: TerminatedVarian Medical Systems Inc.
Medical DeviceJul 1, 2015
Stryker Sustainability Solutions Optical Access System recall — FDA Z-1835-2015
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Class IIFDA: TerminatedStryker Sustainability Solutions
Medical DeviceJul 1, 2015
Teleflex Medical Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson recall — FDA Z-1809-2015
The intake port may be blocked which can cause the bag to fail to fill.
Class IFDA: TerminatedTeleflex Medical
Medical DeviceJul 1, 2015
Terumo Cardiovascular Systems Custom Cardiovascular Procedure Kits recall — FDA Z-1828-2015
The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a…
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp
Medical DeviceJul 1, 2015
Stryker Sustainability Solutions Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model recall — FDA Z-1834-2015
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Class IIFDA: TerminatedStryker Sustainability Solutions
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.