Browse Device Recalls

2,888 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,888 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 2,888 FDA device recalls in PA.

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Date	Product	Reason	Class	Firm
Aug 15, 2024	STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a...	Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo...	Class II	B Braun Medical Inc
Aug 15, 2024	SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ...	Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood...	Class II	B Braun Medical Inc
Aug 13, 2024	Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resect...	The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(...	Class II	Olympus Corporation of the Americas
Aug 13, 2024	Soltive Premium SuperPulsed Laser - Intended for incision, excision, resectio...	The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(...	Class II	Olympus Corporation of the Americas
Aug 8, 2024	AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo...	Potential for product leakage from the Spin Lock Connector on the distal end of the device due to...	Class II	B. Braun Medical, Inc.
Aug 7, 2024	Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U	Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to...	Class I	B Braun Medical Inc
Jul 18, 2024	prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5	During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis...	Class II	Centinel Spine, Inc.
Jul 18, 2024	prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog...	During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis...	Class II	Centinel Spine, Inc.
Jul 16, 2024	Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev...	Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a...	Class I	Philips Respironics, Inc.
Jul 16, 2024	Trilogy Evo Universal Ventilator, Model No. DS2000X11B	Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a...	Class I	Philips Respironics, Inc.
Jul 16, 2024	Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust...	Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a...	Class I	Philips Respironics, Inc.
Jul 3, 2024	Sensis Vibe systems with software version VD15B-Intended to be used as a diag...	If the Sensis documentation functionality is used during adding of once-per-study reporting event...	Class II	Siemens Medical Solutions USA, Inc
Jul 3, 2024	Sensis Vibe systems with software version VD15B in combination with AXIOM Se...	If the Sensis documentation functionality is used during adding of once-per-study reporting event...	Class II	Siemens Medical Solutions USA, Inc
Jul 3, 2024	Sensis Vibe systems with software version VD15B in combination with VM VIRTUA...	If the Sensis documentation functionality is used during adding of once-per-study reporting event...	Class II	Siemens Medical Solutions USA, Inc
Jul 3, 2024	Sensis Vibe systems with software version VD15B in combination with Sensis Hi...	If the Sensis documentation functionality is used during adding of once-per-study reporting event...	Class II	Siemens Medical Solutions USA, Inc
Jul 2, 2024	Multitom Rax -Intended to visualize anatomical structures by converting an x-...	The support arm may unintentionally lower resulting in injury to persons when they are under the ...	Class II	Siemens Medical Solutions USA, Inc
Jul 2, 2024	Luminos dRF Max- Intended to visualize anatomical structures by converting an...	The support arm may unintentionally lower resulting in injury to persons when they are under the ...	Class II	Siemens Medical Solutions USA, Inc
Jul 2, 2024	Luminos Agile Max -Intended to visualize anatomical structures by converting ...	The support arm may unintentionally lower resulting in injury to persons when they are under the ...	Class II	Siemens Medical Solutions USA, Inc
Jul 2, 2024	LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ...	The support arm may unintentionally lower resulting in injury to persons when they are under the ...	Class II	Siemens Medical Solutions USA, Inc
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jul 1, 2024	The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ...	Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach	Class II	Olympus Corporation of the Americas
Jun 21, 2024	ESG-410 Electrosurgical Generator- In conjunction with electrosurgical access...	Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating...	Class II	Olympus Corporation of the Americas
Jun 17, 2024	Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, Inc.
Jun 17, 2024	Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow...	Potential for the backcheck valve to malfunction, resulting in backflow of medication from second...	Class II	B. Braun Medical, 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.