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
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
Mar 7, 2022 syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Num... Upgraded software version makes an automatic change in laser configuration settings for "markerle... Class II Siemens Medical Solutions USA, Inc
Mar 7, 2022 SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now ... Software error may result in sporadic problems causing scanning workflow interruptions, unexpecte... Class II Siemens Medical Solutions USA, Inc
Mar 4, 2022 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVI... The product was distributed without FDA authorization or clearance for marketing and distribution... Class I SML Distribution, LLC
Feb 25, 2022 syngo Application software VE20 (Material Number 10848815) installed on the ... After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and ve... Class II Siemens Medical Solutions USA, Inc
Feb 25, 2022 Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE... Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... Class II Siemens Medical Solutions USA, Inc
Feb 25, 2022 Artis icono biplane- in combination with a Siemens Healthineers table or Tru... Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... Class II Siemens Medical Solutions USA, Inc
Feb 25, 2022 Artis icono floor in combination with a Siemens Healthineers table or Trumpf... Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zeego, Model Number 10280959 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee floor, Model Number 10094135 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q.zen ceiling, Model Number 10848354 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q biplane, Model Number 10848282 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q.zen biplane, Model Number 10848355 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee ceiling, Model Number 10094137 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q floor, Model Number 10848280 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee biplane MN, Model Number 10094143 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee multi-purpose, Model Number 10094139 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee biplane, Model Number 10094141 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q.zen floor, Model Number 10848353 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q zeego, Model Number 10848283 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis Q ceiling, Model Number 10848281 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 23, 2022 Artis zee floor MN, Model Number 10094142 If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... Class II Siemens Medical Solutions USA, Inc
Feb 14, 2022 Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... Cybersecurity Improvement Action-not equipped against potential cyber security threats Class II Draeger Medical, Inc.
Feb 14, 2022 Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... Cybersecurity Improvement Action-not equipped against potential cyber security threats Class II Draeger Medical, Inc.
Feb 7, 2022 PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... Units not properly inspected prior to release to the market, may not function as indicated in the... Class II B Braun Medical Inc
Jan 31, 2022 Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... Class II Siemens Medical Solutions USA, Inc
Jan 31, 2022 Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dis... This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of... Class II B. Braun Medical, Inc.
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Dec 23, 2021 Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) Class II Olympus Corporation of the Americas
Dec 22, 2021 Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135... Philips has identified a specific lot of non-conforming material manufactured by one of its suppl... Class I Philips Respironics, 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.