Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endoss... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implan... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implan... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous d... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous den... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 14, 2016 | BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental im... | A limited number of product pouches may not have been sealed during packaging. | Class II | Biomet 3i, LLC |
| Sep 13, 2016 | LipiFlow thermal Pulsation System, consisting of Console and Activator, Model... | Complaints related to an error condition occurring during patient treatment where the FipiFlow Sy... | Class II | Tearscience, Inc |
| Sep 13, 2016 | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and P... | Varian Medical Systems has received a report that a user was able to easily rotate the head frame... | Class II | Varian Medical Systems, Inc. |
| 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 |
| Sep 12, 2016 | Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by e... | A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. | Class II | A & D Enginering Inc |
| Sep 9, 2016 | Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile ... | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... | Class II | Teleflex Medical |
| Sep 9, 2016 | Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile... | The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johan... | Class II | Teleflex Medical |
| Sep 9, 2016 | SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum... | Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr typ... | Class II | Akita Sumitomo Bakelite Co., Ltd. |
| Sep 9, 2016 | SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M ... | Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type | Class II | Akita Sumitomo Bakelite Co., Ltd. |
| Sep 9, 2016 | Zero-Gravity Radiation Protection System Radiology Personnel protective shi... | Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise... | Class II | Contour Fabricators Inc |
| Sep 8, 2016 | TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics ... | Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Cen... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Sep 8, 2016 | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. ... | The supplier initiated a recall because affected lots of the micro-introducer have an outer diame... | Class II | Argon Medical Devices, Inc |
| Sep 8, 2016 | Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer... | Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR ... | Class II | Greatbatch Medical |
| Sep 7, 2016 | IgE Calibrator Series | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now ... | Class II | Randox Laboratories Ltd. |
| Sep 7, 2016 | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the f... | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Sep 7, 2016 | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Dis... | Mislabeling of the "expiration date". The expiration date on the outer box and the individual po... | Class II | Ellman International, Inc. |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laprosc... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Sep 7, 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Therm... | Ortho confirmed that it is possible for the mis-association of sample identification and assay re... | Class II | Ortho-Clinical Diagnostics |
| Sep 7, 2016 | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily im... | The device has the potential to be packaged in the wrong product box. | Class II | Osteogenics Biomedical, Inc. |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Lapr... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Sep 6, 2016 | Syngo.plaza VB10A, Picture Archiving and Communication System | Software upgrade to eliminate several issues | Class II | Siemens Medical Solutions USA, Inc |
| Sep 6, 2016 | AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro ... | Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lea... | Class II | Beckman Coulter Inc. |
| Sep 6, 2016 | Syngo.plaza, Picture Archiving and Communication System | Software upgrade to eliminate several issues | Class II | Siemens Medical Solutions USA, Inc |
| Sep 5, 2016 | Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySo... | The intraocular lens could become lodged within the cartridge | Class II | Alcon Research, Ltd. |
| Sep 2, 2016 | Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812,... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Sep 2, 2016 | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, ... | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 4... | Class III | Siemens Healthcare Diagnostics Inc |
| Sep 2, 2016 | HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD th... | Labeling inconsistency | Class II | Arrow International Inc |
| Sep 2, 2016 | 2000 Vascular with 30 Degree option | Potential for bed to drop suddenly at the head while a patient is laying on it. | Class II | Heritage Medical Products, Inc. |
| Sep 2, 2016 | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 ... | Screws were identified as having the incorrect part number and lot number marked upon them. The ... | Class II | Trilliant Surgical Ltd. |
| Sep 1, 2016 | Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifuncti... | There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillat... | Class I | Leonhard Lang Medizintechnik GmbH |
| Sep 1, 2016 | RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radi... | RaySearch became aware of the problem as it was discovered in cooperation with a customer experim... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 1, 2016 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 | Adhesive border was not sticky enough. | Class II | CellEra LLC |
| Sep 1, 2016 | Visualase Body Accessory Kit PN 020-3000. The individual components within th... | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... | Class II | Medtronic Navigation, Inc. |
| Sep 1, 2016 | Visualase Visualization Stylets PN 020-2301. The individual components within... | Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Sty... | Class II | Medtronic Navigation, Inc. |
| Aug 31, 2016 | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. | GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involv... | Class II | GE Healthcare, LLC |
| Aug 31, 2016 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P0... | The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... | Class II | Neusoft Medical Systems Co., Ltd. |
| Aug 31, 2016 | NeuViz 64 Multi-slice CT Scanner Systems | The Firm discovered during contrast agent tracking scan, when the expected concentration of contr... | Class II | Neusoft Medical Systems Co., Ltd. |
| Aug 31, 2016 | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex X... | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration d... | Class II | Ormco/Sybronendo |
| Aug 30, 2016 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | Carry bar which is an accessory to a lift used for patients in hospitals and ... | The black plastic puck on the carry bar is breaking resulting in potential for patient harm. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Aug 29, 2016 | CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-02... | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could resul... | Class II | ConMed Corporation |
| Aug 29, 2016 | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, R... | Stryker received several complaints describing incidence of harm secondary to taper lock failure ... | Class II | Stryker Howmedica Osteonics Corp. |
| Aug 29, 2016 | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier ... | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem pac... | Class II | Angiodynamics Inc. (Navilyst Medical 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.