Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2016 | Radial Artery Catheterization Kit with Sharps Safety Features Permits access... | Shipping carton labeling error. | Class II | Arrow International Inc |
| Aug 2, 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassett... | Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. | Class III | Alere San Diego, Inc. |
| Jul 29, 2016 | ROSA BRAIN 3.0.0 | Non-conforming product label. | Class II | Zimmer Biomet, Inc. |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 26, 2016 | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... | Class II | Encore Medical, Lp |
| Jul 25, 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled con... | Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tu... | Class II | Terumo Cardiovascular Systems Corp |
| Jul 21, 2016 | FPS 35mm x 3.5 mm non-locking screw | Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. | Class II | Ortho Solutions Inc |
| Jul 21, 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... | Class II | Integra LifeSciences Corp. |
| Jul 18, 2016 | MACH Cranial Treon. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | MACH AxiEM Cranial Treon. The software application is sent in CD format with ... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Synergy Spine. The software application is sent in CD format with an IFU, wra... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | Fusion ENT Application. The software application is sent in CD format with an... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label s... | Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Th... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jul 18, 2016 | Synergy Cranial S7. The software application is sent in CD format with an IFU... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | FrameLink. The software application is sent in CD format with an IFU, wrapped... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 18, 2016 | S7 MACH FrameLink. The software application is sent in CD format with an IFU,... | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation Stealt... | Class II | Medtronic Navigation, Inc. |
| Jul 15, 2016 | cobas p 501 Post-Analytical Unit calculator/data processing module, for clin... | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 12, 2016 | Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with... | Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain... | Class II | Resmed Corporation |
| Jul 8, 2016 | Diamond Coated Tips and Burs are accessories to the air powered Bone drill (V... | Through an error, the labeling failed to include the symbol or other text indicating that the di... | Class II | Nakanishi Inc. |
| Jul 8, 2016 | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS... | Through an error, the labeling failed to include the symbol or other text indicating that the di... | Class II | Nakanishi Inc. |
| Jul 8, 2016 | Diamond Coated Tips and Burs are accessories to the air powered dental handpi... | Through an error, the labeling failed to include the symbol or other text indicating that the di... | Class II | Nakanishi Inc. |
| Jul 7, 2016 | Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to ... | Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This state... | Class II | TZ Medical, Inc. |
| Jul 7, 2016 | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is ... | Arrow is recalling due to incorrect labeling of products. | Class II | Arrow International Inc |
| Jul 6, 2016 | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1),... | The labels correctly state that the product should be a 25mm screw, but the box contained a longe... | Class II | Smith & Nephew, Inc. |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... | Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . ... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width pla... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimme... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width pla... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Wid... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. T... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 4, 2016 | Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate i... | The surface coating applied to the device is blistering, peeling and discoloring after usage over... | Class II | Zimmer Surgical Inc |
| Jul 1, 2016 | Mentor MemoryGel Breast Implant; Indicated for females for breast augmentatio... | The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. | Class II | Mentor Texas, LP. |
| Jun 30, 2016 | PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intend... | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212... | Class II | MicroPort Orthopedics Inc. |
| Jun 30, 2016 | Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled ster... | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... | Class II | Zimmer Biomet Spine, Inc |
| Jun 30, 2016 | Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled ... | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrumen... | Class II | Zimmer Biomet Spine, Inc |
| Jun 30, 2016 | AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indic... | Vision RT Ltd received three (3) reports from different sites that discovered the following issue... | Class II | Vision RT Ltd |
| 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 29, 2016 | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK St... | Labeling problem | Class III | C.R. Bard, Inc. |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jun 29, 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module ... | The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packag... | Class II | Carefusion 2200 Inc |
| Jun 27, 2016 | Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Su... | After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade c... | Class II | Aspen Surgical Puerto Rico Corp. |
| Jun 24, 2016 | Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a sing... | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year... | Class II | Danville Materials, Inc. |
| Jun 23, 2016 | DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 6400... | Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Mod... | Class II | Medtronic Neuromodulation |
| Jun 23, 2016 | Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on... | Varian Medical Systems has received reports that unintended changes were made to planned couch pa... | Class II | Varian Medical Systems, Inc. |
| Jun 22, 2016 | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, 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.