Browse Device Recalls

162 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 162 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 162 FDA device recalls.

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DateProductReasonClassFirm
May 23, 2016 TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 ... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Ti... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 ... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 T... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Tit... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
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 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
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
Apr 18, 2016 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Prod... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 18, 2016 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product U... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 4, 2016 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #... This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped afte... Class II Synthes (USA) Products LLC
Feb 23, 2016 Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... Out of specification at the thread. The thread height of these screws is under-sized. The cross s... Class II Synthes (USA) Products LLC
Feb 23, 2016 Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, ... Out of specification at the thread. The thread height of these screws is under-sized. The cross s... Class II Synthes (USA) Products LLC
Feb 18, 2016 Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion ca... The label on the outer packaging does not match the product inside and intended use of the device. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guid... DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking... Class II Synthes (USA) Products LLC
Feb 16, 2016 3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Scr... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Feb 16, 2016 4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and ... Labeling does not match the cleared indications for use in the United States and Canada. Class II Synthes (USA) Products LLC
Jan 6, 2016 Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw... DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Can... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 1, 2015 SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexi... The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual di... Class II Synthes (USA) Products LLC
Nov 2, 2015 Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/R... TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent ... Class II Synthes (USA) Products LLC
Nov 2, 2015 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixat... It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the inco... Class II Synthes (USA) Products LLC
Oct 19, 2015 Synthes Application Instrument for Sternal ZIPFIX. Indications for use incl... Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on Au... Class II Synthes (USA) Products LLC
Oct 8, 2015 Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/... The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indi... Class II Synthes (USA) Products LLC
Oct 7, 2015 Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324... The affected part number and lot listed above is incorrectly etched with the wrong part number an... Class II Synthes (USA) Products LLC
Oct 6, 2015 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes mod... Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. Class II Synthes (USA) Products LLC
Sep 28, 2015 Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile... The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41... Class II Synthes (USA) Products LLC
Sep 21, 2015 Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. ... Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the ... Class II Synthes (USA) Products LLC
Sep 14, 2015 Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates an... Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120... Class II Synthes (USA) Products LLC
Sep 4, 2015 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Uni... This product was produced using a finishing process not identified as part of the manufacturing s... Class II Synthes (USA) Products LLC
Sep 3, 2015 Inserter for Titanium Elastic Nails (TEN), orthopedic device potential for mechanical failures such as breakage. Class II Synthes (USA) Products LLC
Aug 31, 2015 Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The S... The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled M... Class II Synthes (USA) Products LLC
Aug 11, 2015 Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm;... DLS pin breakage during planned implant removal, after uneventful and successful healing of the f... Class II Synthes (USA) Products LLC
Jul 29, 2015 VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also know... The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the c... Class II Synthes (USA) Products LLC
Jul 29, 2015 Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sci... Potential for micropores to form, allowing fluid to enter the hollow handle. Class II Synthes (USA) Products LLC
Jul 29, 2015 Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) an... Labeling changes were made related to MR conditions that align with standard definitions for MR S... Class II Synthes (USA) Products LLC

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.