Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2016 | OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... | Failed stability testing at 8 months. This lot produced intermittent false negative results for ... | Class I | OraSure Technologies, Inc. |
| Jul 13, 2016 | SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 co... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, c... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Ar... | The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, co... | Due to an internal communication error between the firmware and the software of the components, t... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / ze... | The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2016 | ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic ... | The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 11, 2016 | Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DEx... | B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tr... | Class II | B. Braun Medical, Inc. |
| Jul 7, 2016 | Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Mo... | Due to an error in the 19 Live Display, image reproduction may fail in the examination room and ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 7, 2016 | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is ... | Arrow is recalling due to incorrect labeling of products. | Class II | Arrow International Inc |
| 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 23, 2016 | Syngo.via, picture archiving and communications system software controlled. ... | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 23, 2016 | OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector | New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when usi... | Class II | Olympus Corporation of the Americas |
| Jun 22, 2016 | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #... | Risk associated with operating the device in skin temperature mode with temperature sensors attac... | Class II | Draeger Medical, Inc. |
| Jun 9, 2016 | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDR... | Bayer Healthcare is initiating this recall due to complaints that were received from customer sit... | Class II | Bayer Healthcare |
| 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 |
| Jun 6, 2016 | SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... | Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... | Class II | Siemens Medical Solutions USA, 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 |
| 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 |
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.