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 |
|---|---|---|---|---|
| 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. |
| 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. |
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.