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.

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DateProductReasonClassFirm
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.