Browse Device Recalls
249 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 249 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 249 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2015 | Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Univer... | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to t... | Class II | Integra LifeSciences Corp. |
| May 27, 2015 | Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt ... | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because t... | Class II | Integra LifeSciences Corp. |
| May 1, 2015 | Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... | Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | The Integra Camino ICP Monitor is a compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 M... | Class II | Integra LifeSciences Corp. |
| Apr 14, 2015 | The Integra Licox Pt02 Monitors are compact, portable device for use with Pre... | Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 ... | Class II | Integra LifeSciences Corp. |
| Mar 30, 2015 | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gaug... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Mar 13, 2015 | Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile dev... | A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 w... | Class II | Integra LifeSciences Corp. |
| Nov 7, 2014 | Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxyg... | Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since Oc... | Class II | Integra LifeSciences Corp. |
| Nov 6, 2014 | Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace th... | Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CM... | Class II | Integra LifeSciences Corp. |
| Oct 24, 2014 | Integra Titan Reverse Shoulder System right and left head cutting templates, ... | A single lot of left and a single lot of right Reverse Shoulder System cutting templates were man... | Class II | Integra LifeSciences Corp. |
| Sep 29, 2014 | Integra Selector Kit Sterile single use device A bi-lumen, sterile single us... | Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not pla... | Class II | Integra LifeSciences Corp. |
| Aug 18, 2014 | Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Irel... | Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monito... | Class II | Integra LifeSciences Corp. |
| Jul 9, 2014 | Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat.... | Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of rev... | Class II | Integra LifeSciences Corp. |
| Jun 27, 2014 | Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray ... | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility t... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2014 | Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED... | LED battery chargers may prematurely fail and will not charge the LED battery as intended | Class II | Integra LifeSciences Corp. |
| Jun 9, 2014 | MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60... | Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees of... | Class II | Integra LifeSciences Corp. |
| May 19, 2014 | Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 ... | This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that de... | Class II | Integra LifeSciences Corp. |
| Apr 16, 2014 | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use wi... | Integra LifeSciences has identified through a small number of complaints that some lot numbers of... | Class II | Integra LifeSciences Corp. |
| Mar 10, 2014 | Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ ... | Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert i... | Class II | Integra LifeSciences Corp. |
| Jan 22, 2014 | Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxi... | Integra LifeSciences has identified through an investigation of complaints that there may be the ... | Class II | Integra LifeSciences Corp. |
| Dec 5, 2013 | Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Produc... | The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position. | Class II | Integra LifeSciences Corp. |
| Nov 26, 2013 | Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neu... | Integra became aware through a complaint from a single non-US customer that if the optional SYS/D... | Class II | Integra LifeSciences Corp. |
| Nov 26, 2013 | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial... | Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Nov 13, 2013 | Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... | Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... | Class II | Integra LifeSciences Corp. |
| Nov 13, 2013 | Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... | Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... | Class II | Integra LifeSciences Corp. |
| Oct 28, 2013 | Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Numbe... | Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesi... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Sep 4, 2013 | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INS... | Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integr... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 29, 2013 | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Cla... | An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not eas... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit R... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Pro... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 11, 2013 | Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit ... | Integra LifeSciences Corporation has determined that there is a possibility that some lots of Lic... | Class II | Integra LifeSciences Corp. |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| Feb 12, 2013 | Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in ... | Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions alrea... | Class II | Integra LifeSciences Corp. |
| Feb 1, 2013 | Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and can... | The firm has received numerous complaints of the cannulated screw driver tip breaking during surg... | Class II | Integra LifeSciences Corp. |
| Jan 7, 2013 | Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecon... | There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the... | Class II | Integra LifeSciences Corp. |
| Dec 21, 2012 | MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integ... | Integra determined there is a possibility that the Base Units may break during use. | Class II | Integra LifeSciences Corp. |
| Dec 10, 2012 | Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning... | Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occu... | Class II | Integra LifeSciences Corp. |
| Jun 7, 2012 | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve... | Class III | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Feb 9, 2012 | Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive... | Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during su... | Class II | Integra LifeSciences Corp. |
| Oct 11, 2011 | Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is... | The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l f... | Class II | Integra LifeSciences Corp. |
| Oct 11, 2011 | Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft ... | The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for... | Class II | Integra LifeSciences Corp. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.