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 |
|---|---|---|---|---|
| Nov 9, 2022 | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3... | When selecting the site fraction group for treatment, the User may select the wrong site for trea... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 4, 2022 | HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S | An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be c... | Class II | Olympus Corporation of the Americas |
| Sep 28, 2022 | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the so... | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, i... | Class II | X-NAV Technologies, LLC |
| Sep 27, 2022 | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Us... | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 27, 2022 | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | The subject products are being recalled because they contain the incorrect size drill guide and w... | Class II | Synthes (USA) Products LLC |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 19, 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie... | Class II | DeVilbiss Healthcare LLC |
| Sep 16, 2022 | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical a... | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of acces... | Class II | Olympus Corporation of the Americas |
| Sep 15, 2022 | Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per ca... | The extension set has a high probability of failure which could lead to possible leakage or detac... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 uni... | The extension set has a high probability of failure which could lead to possible leakage or deta... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per c... | The extension set has a high probability of potential failure which could lead to possible leakag... | Class II | B. Braun Medical, Inc. |
| Sep 6, 2022 | Philips Respironics DreamWear Full Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Therapy Mask 3100 NC/SP | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Philips Respironics Amara View Minimal Contact Full-Face Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | DreamWisp Nasal Mask with Over the Nose Cushion | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 6, 2022 | Wisp and Wisp Youth Nasal Mask | No contraindication/warning regarding magnetic components in CPAP masks for patients with implant... | Class I | Philips Respironics, Inc. |
| Sep 1, 2022 | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive ant... | Potential for leakage at the catheter hub. | Class II | B Braun Medical Inc |
| Aug 30, 2022 | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... | Class II | Synthes (USA) Products LLC |
| Aug 26, 2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation suppo... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive v... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 12, 2022 | Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION ... | An out of specification component preventing the blue retention ring from keeping the rotation kn... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2022 | Artis pheno- Model No. 10849000 | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis... | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 21, 2022 | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model... | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen ... | Class I | Cardiac Assist, Inc |
| Jul 15, 2022 | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... | Potential for the incorrect screw to be included in the package. | Class II | Aesculap Implant Systems LLC |
| Jul 14, 2022 | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... | Class II | Aesculap Implant Systems LLC |
| Jul 12, 2022 | AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... | The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... | Class III | Siemens Medical Solutions USA, Inc |
| Jul 7, 2022 | ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S | Mis-wired component-the improperly wired component can result in additional noise on the power su... | Class II | Olympus Corporation of the Americas |
| Jun 15, 2022 | Sensis Vibe Combo with software version VD12A. A diagnostic and administrati... | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 15, 2022 | Sensis with software version VD12A. A diagnostic and administrative tool su... | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 10, 2022 | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 | A video signal from one of the transceivers of the Large Display may be lost. In very rare cases,... | Class II | Siemens Medical Solutions USA, Inc |
| May 26, 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150... | Device model and size for affected lots of Laser Fibers may be mismatched between the product's c... | Class II | Olympus Corporation of the Americas |
| May 24, 2022 | Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Int... | It may occur that after system startup no stand movement is possible any longer in the event of a... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2022 | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enume... | High number of total images/unassigned events including (dual positives) and the potential for fa... | Class II | Menarini Silicon Biosystems |
| May 20, 2022 | Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509... | The firm has initiated this recall to replace component on devices distributed containing a compo... | Class II | Draeger Medical Systems, Inc. |
| May 20, 2022 | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 | During system tests, an increased wearing of the Image acquisition system fans has been observed.... | Class II | Siemens Medical Solutions USA, Inc |
| May 16, 2022 | Drager SafeStar 55, Catalog No. MP01790 | Possible occlusion of filters due to manufacturing error. | Class I | Draeger Medical, Inc. |
| Apr 22, 2022 | Colonovideoscope Model CF-H180AL | A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the ... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2022 | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper ... | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used ... | Class II | Olympus Corporation of the Americas |
| Apr 21, 2022 | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400... | Class II | Oakworks Inc |
| Apr 21, 2022 | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 | Product label was printed without the UDI number and warning label was printed with the incorrect... | Class II | Oakworks 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.