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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 20, 2022 | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 13, 2022 | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 ... | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis L... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | Artis icono floor-angiography systems developed for single and biplane diagno... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | Artis icono biplane -angiography systems developed for single and biplane dia... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2022 | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 9, 2022 | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test | Firm distributed tests which have not been cleared or authorized for marketing or distribution in... | Class I | Woodside Acquisitions Inc. |
| Apr 7, 2022 | Radial Head Replacement System Implant is a one-piece, stemmed radial head re... | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions f... | Class II | Synthes (USA) Products LLC |
| Mar 31, 2022 | Olympus DISPOSABLE GRASPING FORCEPS, FG-51D | Forceps do not comply with Olympus standards for the amount of force required to open and close t... | Class II | Olympus Corporation of the Americas |
| Mar 25, 2022 | Olympus Uretero-reno videoscope, Model No. URF-V2 | The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulatio... | Class II | Olympus Corporation of the Americas |
| Mar 18, 2022 | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time... | GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-1TQ180: EVIS EXERA II Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-MP60: OES Bronchofiberscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-MP160F: EVIS EXERA Bronchofibervideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 8, 2022 | BF-3C160: EVIS EXERA Bronchovideoscope | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessin... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2022 | YSIO X.Pree | For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparati... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Mod... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Nu... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number ... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | 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.