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
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.