Medical DeviceDec 31, 2014
Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm recall — FDA Z-0865-2015
The cuff inflation line may detach from the endotracheal tube during use.
Class IFDA: TerminatedHalyard Health
30,447medical device recall records
2,766FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1223
30,447 detailed records are currently available in this category.
Medical DeviceDec 31, 2014
Unistrip Technologies UniStrip1, Blood Glucose Test Strips, 50 count box recall — FDA Z-0855-2015
Failure to submit a 510(k) for device labeling changes.
Class IIFDA: TerminatedUnistrip Technologies LLC
Medical DeviceDec 31, 2014
Halyard Health KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm recall — FDA Z-0868-2015
The cuff inflation line may detach from the endotracheal tube during use.
Class IFDA: TerminatedHalyard Health
Medical DeviceDec 31, 2014
Advanced Sterilization Products STERRAD 100S, Product Code 10113 recall — FDA Z-0843-2015
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure…
Class IIFDA: TerminatedAdvanced Sterilization Products
Medical DeviceDec 31, 2014
Cyberonics VNS Therapy AspireHC, Model 105 Generator recall — FDA Z-0858-2015
The recalled product was distributed with an incorrect serial number printed on the device's label.
Class IIFDA: TerminatedCyberonics, Inc.
Medical DeviceDec 31, 2014
Heart Sync ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with recall — FDA Z-0586-2015
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous…
Class IFDA: TerminatedHeart Sync, Inc.
Medical DeviceDec 31, 2014
Ortho-Clinical Diagnostics VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in recall — FDA Z-0848-2015
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceDec 31, 2014
Horiba Instruments Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and recall — FDA Z-0856-2015
HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to…
Class IIFDA: TerminatedHoriba Instruments Inc.
Medical DeviceDec 31, 2014
Iris Diagnostics RTH8 Rotor, P/N X01-005847-001 recall — FDA Z-0857-2015
Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.
Class IIFDA: TerminatedIris Diagnostics
Medical DeviceDec 31, 2014
Instrumentation Laboratory Co HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation recall — FDA Z-0832-2015
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker)…
Class IIFDA: TerminatedInstrumentation Laboratory Co.
Medical DeviceDec 31, 2014
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb recall — FDA Z-0862-2015
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Class IIFDA: TerminatedBausch & Lomb Inc.
Medical DeviceDec 31, 2014
Invacare Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit recall — FDA Z-0872-2015
The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
Class IIFDA: TerminatedInvacare Corporation
Medical DeviceDec 31, 2014
Heart Sync ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For recall — FDA Z-0584-2015
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous…
Class IFDA: TerminatedHeart Sync, Inc.
Medical DeviceDec 31, 2014
Advanced Sterilization Products STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are recall — FDA Z-0846-2015
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure…
Class IIFDA: TerminatedAdvanced Sterilization Products
Medical DeviceDec 31, 2014
Ge Healthcare It Centricity Enterprise Archive is a software product for receiving recall — FDA Z-0833-2015
GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.
Class IIFDA: TerminatedGe Healthcare It
Medical DeviceDec 31, 2014
Advanced Sterilization Products STERRAD 50, Product Code 10114 recall — FDA Z-0842-2015
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure…
Class IIFDA: TerminatedAdvanced Sterilization Products
Medical DeviceDec 24, 2014
Stryker Endoscopy PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic recall — FDA Z-0596-2015
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide…
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceDec 24, 2014
Stryker Endoscopy PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267 recall — FDA Z-0646-2015
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide…
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceDec 24, 2014
Philips Ultrasound Additional devices identified in new FSN MA-FCO 83000190: QLAB versions recall — FDA Z-0815-2015
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular…
Class IIFDA: TerminatedPhilips Ultrasound, Inc.
Medical DeviceDec 24, 2014
Philips Ultrasound EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or recall — FDA Z-0817-2015
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular…
Class IIFDA: TerminatedPhilips Ultrasound, Inc.
Medical DeviceDec 24, 2014
Stryker Endoscopy PKG, ALLIGATOR FORCEPS, P/N 0250080316 recall — FDA Z-0679-2015
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide…
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceDec 24, 2014
Stryker Endoscopy PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic recall — FDA Z-0748-2015
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide…
Class IIFDA: TerminatedStryker Endoscopy
Medical DeviceDec 24, 2014
AGFA Healthcare Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x recall — FDA Z-0804-2015
Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.
Class IIIFDA: TerminatedAGFA Healthcare Corp.
Medical DeviceDec 24, 2014
Stryker Endoscopy PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual recall — FDA Z-0595-2015
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide…
Class IIFDA: TerminatedStryker Endoscopy
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.