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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 21, 2020 | STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usa... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Sep 21, 2020 | END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 ... | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... | Class III | Synthes (USA) Products LLC |
| Jul 21, 2020 | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm -... | May have one or more dimensional features out of tolerance includes: thread pitch diameter depth,... | Class II | Synthes (USA) Products LLC |
| Sep 16, 2019 | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 fo... | The subject product measures 4.0mm in diameter instead of 3.5mm. | Class II | Synthes (USA) Products LLC |
| Sep 5, 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with ... | Modified outside of approved manufacturing process | Class II | Synthes (USA) Products LLC |
| Sep 12, 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 ... | The product inside the package does not match the label. The product was labeled as long thread ... | Class II | Synthes (USA) Products LLC |
| May 4, 2018 | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used... | The adapter may demonstrate a degradation of function as the final products were assembled with b... | Class II | Synthes (USA) Products LLC |
| Apr 2, 2018 | Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Apr 2, 2018 | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Mar 5, 2018 | Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Mar 5, 2018 | Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Mar 5, 2018 | Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 35... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S ... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 26, 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Ream... | Possible lack of product sterility due to potential gaps/channeling in the seal of the package. | Class II | Synthes (USA) Products LLC |
| Jul 21, 2017 | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | The locking mechanism and protective cap were missing from the sterile packed nails of the affect... | Class II | Synthes (USA) Products LLC |
| Jan 31, 2017 | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. ... | These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820... | Class II | Synthes (USA) Products LLC |
| Dec 29, 2016 | Synthes Radial Head Prosthesis System, Surgical instrument motors and accesso... | There is the possibility that the radial stem may loosen post-operatively at the stem bone interf... | Class II | Synthes (USA) Products LLC |
| Nov 29, 2016 | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/I... | The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to ... | Class II | Synthes (USA) Products LLC |
| Nov 1, 2016 | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm ... | Class II | Synthes (USA) Products LLC |
| Oct 31, 2016 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible... | Non-conforming material used. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 3.0 mm Reaming Rod/950 mm, Sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Oct 3, 2016 | Extraction Hook - Sterile for TI Cannulated Nails | The peel pouches for the affected reaming rods and extraction hooks are delaminating. | Class II | Synthes (USA) Products LLC |
| Jun 28, 2016 | Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm... | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Sta... | Class II | Synthes (USA) Products LLC |
| Jun 7, 2016 | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw ... | DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (P... | Class II | Synthes (USA) Products LLC |
| 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 23, 2016 | TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 T... | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... | 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.