Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jun 22, 2016 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... | Incorrect top label on an implant package. | Class II | Nobel Biocare Usa Llc |
| Jun 22, 2016 | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 22, 2016 | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 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 | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... | The Positive Control information referencing human plasma as the antibody material described in t... | Class III | Alere San Diego, Inc. |
| Jun 13, 2016 | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx O... | The pouch label was missing the use by date (UBD) of 2018-04. | Class II | Cardiovascular Systems Inc |
| 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. |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-... | There is a potential for stylet stiffening that is not accurately represented on the labeling. Th... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jun 8, 2016 | AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 1... | The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling ... | Class II | Amd-Ritmed, Inc. |
| Jun 2, 2016 | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... | Class II | Arrow International Inc |
| Jun 2, 2016 | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K ... | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and... | Class II | Arrow International Inc |
| Jun 2, 2016 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS... | Arrow is recalling these products due to the possibility that although the kit is labeled as cont... | Class II | Arrow International Inc |
| Jun 1, 2016 | PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoeni... | BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the fol... | Class III | Becton Dickinson & Co. |
| Jun 1, 2016 | PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix ... | BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following... | Class III | Becton Dickinson & Co. |
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.