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Browse Device Recalls

2,862 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,862 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 2,862 FDA device recalls in PA.

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DateProductReasonClassFirm
Feb 2, 2026 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Feb 2, 2026 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. Class II B Braun Medical Inc
Jan 29, 2026 Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 29, 2026 Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... Potential for rubber fragment detachment during use. Class II Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 16, 2026 Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... Issue with software algorithm which may lead to overpressure events. Class I Olympus Corporation of the Americas
Jan 15, 2026 Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM ... There is the potential for the length of the trocar shaft to be too long. Class II Aesculap Inc
Jan 8, 2026 Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product ... Mis-wired component-the improperly wired component can result in additional noise on the power su... Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable ... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Mod... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: K... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Jan 7, 2026 Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... Devices which did not undergo thermoforming could deform and lose performance. Class II Olympus Corporation of the Americas
Dec 31, 2025 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 ... Products were mislabeled as the 6mm product but included the 5 mm product. Class II Centinel Spine, Inc.
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 19, 2025 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... The supplier manufactured anatomical left plates with an incorrect thread orientation. Class II Tyber Medical
Dec 11, 2025 Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... Customers may experience inaccurate test results by observing a higher frequency of classificatio... Class II Fujirebio Diagnostics, 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.