Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
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 31, 2016 Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 ... Isolated episodes of leakage at the check valve were found Class I Draeger Medical, Inc.
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
May 23, 2016 DeVilbiss Model 7305P-D Powered Suction Unit A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature fai... Class II DeVilbiss Healthcare LLC
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 9, 2016 Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... Software error in previous software versions in which two references for the same image may exist... Class II Siemens Medical Solutions USA, Inc
May 6, 2016 The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneo... To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleani... Class II Custom Ultrasonics, Inc.
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 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 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 21, 2016 Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bot... Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling proc... Class II Draeger Medical, Inc.
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 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 Syngo Dynamics; Kinetdx Picture Archiving and Communications System Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syng... Class II Siemens Medical Solutions USA, 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 MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, M... The docking station top cover of the removable patient table may contain a magnetic metal plate. ... Class II Siemens Medical Solutions USA, Inc
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
Apr 1, 2016 SOMATOM Force, Computed Tomography x-ray system intended to generate and ... The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly l... Class II Siemens Medical Solutions USA, Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Mar 22, 2016 SOMATOM Definition AS, a family of CT systems intended to produce cross-secti... Siemens became aware that the front cover on some Siemens CT system was not properly welded. It ... Class II Siemens Medical Solutions USA, Inc
Mar 15, 2016 EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus v... New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised man... Class II Olympus Corporation of the Americas
Mar 11, 2016 Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiog... After importing segmentation results of the left atrium created on the Artis One system, the poss... 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.