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 |
|---|---|---|---|---|
| May 31, 2016 | Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 56... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwd... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, ... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot ... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue | DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and o... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lo... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot ... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989,... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 31, 2016 | Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot ... | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed... | Class II | Synthes (USA) Products LLC |
| May 26, 2016 | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... | Class II | Exactech, Inc. |
| May 26, 2016 | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... | Class II | Exactech, Inc. |
| May 25, 2016 | iConnect Access software. The firm name on the label is Merge Healthcare, Ha... | Software displayed incorrect prior reports in the viewport area, only when more than one prior st... | Class II | Merge Healthcare, Inc. |
| May 23, 2016 | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethyl... | Medtronic is issuing a medical device recall to return product potentially associated with an out... | Class II | Ev3, Inc. |
| May 19, 2016 | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MS... | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. | Class II | Devicor Medical Products Inc |
| May 17, 2016 | cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Inf... | Kit labeled with the incorrect expiration date. | Class III | Roche Molecular Systems, Inc. |
| May 11, 2016 | Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bon... | DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... | Class II | Synthes (USA) Products LLC |
| May 11, 2016 | Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bon... | DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... | Class II | Synthes (USA) Products LLC |
| May 11, 2016 | Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bo... | DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and ... | Class II | Synthes (USA) Products LLC |
| May 6, 2016 | Endotine Transbleph 3.5 (CFD-080-0167) | MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167),... | Class II | MicroAire Surgical Instruments, LLC |
| May 5, 2016 | Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individua... | This recall has been initiated due to the product labeled with the incorrect expiration date. | Class II | Medical Components, Inc dba MedComp |
| May 5, 2016 | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.... | The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a... | Class II | Teleflex Medical |
| 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 | 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 |
| 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 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 | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; ... | Mislabeled for size | Class II | Stryker Sustainability Solutions |
| 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 15, 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge... | There are potential issues with results reporting for certain run-based tests. Under certain con... | Class II | Merge Healthcare, Inc. |
| Apr 14, 2016 | Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | Class II | B. Braun Medical, Inc. |
| Apr 14, 2016 | Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208,... | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... | Class II | Biosense Webster, Inc. |
| Apr 14, 2016 | Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D12... | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in ... | Class II | Biosense Webster, Inc. |
| Apr 14, 2016 | Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... | BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... | Class II | B. Braun Medical, Inc. |
| Apr 13, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... | Class II | Merge Healthcare, Inc. |
| Apr 11, 2016 | EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd... | Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in... | Class II | Ethicon, Inc. |
| Apr 8, 2016 | Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... | Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... | Class II | Medtronic Sofamor Danek Usa, Inc - Dallas Distr... |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) ... | Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up ... | Class II | Leica Microsystems, Inc. |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the... | Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the e... | Class II | Leica Microsystems, Inc. |
| Apr 5, 2016 | Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100... | CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following... | Class II | Ceg Enterprises Llc |
| Apr 4, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla... | When taking measurements from images on the Cardio workstation or from the US cart, numbers are n... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the la... | The software produced a number of "do not route" exceptions, which may result in potential pati... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains ... | Product resistance has fallen outside of label claim within expiry. | Class II | Mesa Laboratories Inc |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Me... | System locks up which may result in potential patient injury or delay in diagnosis or treatment. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Potential exists for an incorrect patient image being displayed which could result in the delay i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea... | A situation can occur allowing two physicians to access the same study report in EchoIMS when lau... | Class II | Merge Healthcare, 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.