Browse Device Recalls
791 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 791 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 791 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 16, 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Sep 27, 2017 | Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR... | There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirm... | Class II | WalkMed, LLC |
| Aug 1, 2017 | Presource(R) Kits (custom surgical/procedural kits): The standard and custom... | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ i... | Class II | Cardinal Health 200, LLC |
| Jul 27, 2017 | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... | A leak may allow for microbial contamination of the sterile fluid path. | Class II | Baxter Healthcare Corporation |
| Jul 27, 2017 | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jun 19, 2017 | STAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets ... | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | Class II | ConMed Corporation |
| Jun 19, 2017 | STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administr... | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. | Class II | ConMed Corporation |
| Jun 15, 2017 | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... | The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... | Class II | Custom Assemblies Inc |
| Jun 6, 2017 | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... | Real-time shelf life testing failed at 24 months | Class II | Microbiologics Inc |
| Apr 17, 2017 | AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... | nail not properly engaging with the targeting jig due to certain undersized specification | Class II | Zimmer Biomet, Inc. |
| Apr 6, 2017 | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... | Class II | Amendia, Inc |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme use cases. | Class II | Ethicon Endo-Surgery Inc |
| Mar 20, 2017 | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The A... | Arrow International initiated the recall due to reports of safety cover disengagement and needles... | Class II | Arrow International Inc |
| Mar 7, 2017 | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... | Class II | Aesculap Implant Systems LLC |
| Feb 23, 2017 | Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... | When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 20, 2017 | Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 2002... | The firm information that the product was reporting false positive results | Class II | Gibson Laboratories LLC |
| Dec 16, 2016 | IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 15, 2016 | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c... | A field report indicated some units within this lot were missing the bottom pouch seal. The comp... | Class II | Boston Scientific Corporation |
| Nov 29, 2016 | symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C1313... | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... | Class II | Symmetry Surgical, Inc. |
| Nov 29, 2016 | symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134... | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... | Class II | Symmetry Surgical, Inc. |
| Nov 29, 2016 | symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C1... | Sealant on the base trim of sterilizer container may be deteriorated or absent which could provid... | Class II | Symmetry Surgical, Inc. |
| Oct 26, 2016 | 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Univer... | 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (proces... | Class II | 3M Company - Health Care Business |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. | Class II | DePuy Spine, Inc. |
| Oct 6, 2016 | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... | Class II | AccessClosure, Inc., A Cardinal Health Company |
| Sep 29, 2016 | Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 1... | The insert and case label description of the device incorrectly reads Counter Incrementing Actuat... | Class II | Thayer Medical Corporation |
| Sep 13, 2016 | ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US,... | Customers complained of low/empty reagent vials. | Class II | TEM Systems Inc |
| Aug 16, 2016 | Pathfast D-Dimer, Reference number: PF1051-KUS | Two complaints were received about decrease in sensitivity (control value and/or calibration valu... | Class II | Lsi Medience Corporation |
| Aug 12, 2016 | Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Aug 12, 2016 | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Jul 25, 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 25, 2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... | The batteries have the potential to overheating, melt or char. | Class II | Tecan US, Inc. |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... | Quality control identified a component issue where the pinion gear in the device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| Jul 15, 2016 | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... | Quality control identified a component issue where the pinion gear in the device could fail under... | Class II | Ethicon Endo-Surgery Inc |
| Jun 30, 2016 | Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 30, 2016 | Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... | Class II | Stryker Howmedica Osteonics Corp. |
| Jun 10, 2016 | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... | An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi... | Class II | Dako North America Inc. |
| May 6, 2016 | Ariol is an automated scanning microscope and image analysis system. It is in... | An issue during the manufacturing process caused systems to have an improperly activated Windows ... | Class III | Leica Biosystems Richmond Inc. |
| Mar 31, 2016 | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... | Class III | Biocare Medical, LLC |
| Mar 28, 2016 | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar C... | Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with L... | Class II | Becton Dickinson & Co. |
| Mar 25, 2016 | The Plum 360 is a large volume infuser capable of delivering fluids for a var... | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... | Class II | Hospira Inc. |
| Feb 16, 2016 | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac... | Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract... | Class II | Biomet, Inc. |
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.