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 |
|---|---|---|---|---|
| May 4, 2016 | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapt... | Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the sc... | Class II | Stryker Corporation |
| May 4, 2016 | ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical sc... | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... | Class II | Zimmer Manufacturing B.V. |
| May 4, 2016 | VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 ... | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant ... | Class II | Zimmer Manufacturing B.V. |
| May 4, 2016 | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Ve... | Class II | Brainlab AG |
| May 3, 2016 | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instru... | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femu... | Class II | Materialise USA LLC |
| May 3, 2016 | Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Mod... | Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior ... | Class II | Medtronic Neuromodulation |
| May 2, 2016 | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for f... | Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar... | Class II | Synthes (USA) Products LLC |
| May 2, 2016 | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for qu... | Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nm... | Class II | Siemens Healthcare Diagnostics, Inc |
| May 2, 2016 | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid R... | Labeling errors. The outer packge label expiration date may exceed the expiration date of the su... | Class II | Synthes (USA) Products LLC |
| May 2, 2016 | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid R... | Labeling errors. The outer packge label expiration date may exceed the expiration date of the su... | Class II | Synthes (USA) Products LLC |
| May 2, 2016 | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid R... | Labeling errors. The outer packge label expiration date may exceed the expiration date of the su... | Class II | Synthes (USA) Products LLC |
| May 2, 2016 | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgica... | Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test... | Class II | Synthes (USA) Products LLC |
| May 2, 2016 | CytoVision Image Analysis and Capture System, an automated cell-locating devi... | Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was asso... | Class III | Leica Biosystems Richmond Inc. |
| May 2, 2016 | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. | The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (In... | Class II | Staar Surgical Co. |
| May 2, 2016 | DX-D600 - DXD Imaging Package | One of the dent markers from the DX-D600 dropped down from the overhead rail. | Class II | AGFA Healthcare Corp. |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis th... | As a result of an internal review of all labeling for the Cadence System, it was determined that ... | Class II | Integra LifeSciences Corp. |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 28, 2016 | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision Syst... | Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS ... | Class II | Alcon Research, Ltd. |
| Apr 28, 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ... | Possible presence of foreign material (rust). | Class II | CMP Industries, Llc |
| Apr 28, 2016 | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10... | Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor ... | Class II | Excelsior Medical Corp |
| Apr 28, 2016 | Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic... | Due to the buildup of grease within the hose and motor, the product may require multiple attempts... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Apr 28, 2016 | ADVIA Centaur XPT Immunoassay System | The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 28, 2016 | IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454... | Possible presence of foreign material (rust). | Class II | CMP Industries, Llc |
| Apr 28, 2016 | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; ... | Mislabeled for size | Class II | Stryker Sustainability Solutions |
| Apr 27, 2016 | Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set scr... | There is a possibility that the subject set screw driver could disengage from the torque limiting... | Class II | Orthofix, Inc |
| Apr 26, 2016 | Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distribute... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Apr 26, 2016 | Reprocessed Microline Scissor Tips intended to be used with a reusable hand p... | Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect th... | Class II | STERILMED, INC. |
| Apr 26, 2016 | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: ... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Apr 26, 2016 | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous deliver... | Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle gu... | Class II | B. Braun Medical, Inc. |
| Apr 26, 2016 | Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, N... | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch i... | Class II | Greatbatch Medical |
| Apr 26, 2016 | 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolyt... | The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride a... | Class II | Greiner Bio-One North America, Inc. |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... | Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... | Class III | GSK Consumer Healthcare |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 25, 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... | Class II | Volcano Corporation |
| Apr 25, 2016 | Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scann... | It has been found that if the scan range extends beyond the maximum Field of View (FOV), a recons... | Class II | Toshiba American Medical Systems Inc |
| Apr 25, 2016 | Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemen... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 24, 2016 | Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B... | Potential degradation of detector performance. | Class II | Toshiba American Medical Systems Inc |
| Apr 22, 2016 | BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePo... | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 22, 2016 | BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoin... | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 22, 2016 | Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph True... | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV v... | Class II | Siemens Medical Solutions USA 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.