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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DateProductReasonClassFirm
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 PUMP SET 3 CARESITE LADS 133 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 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
May 31, 2024 Soltive Pro SuperPulsed Laser System, Model TFL-SLS Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has b... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 Soltive Premium SuperPulsed Laser System, Model TFL-PLS Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examin... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 30, 2024 Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part numb... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
May 30, 2024 Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is ... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
May 17, 2024 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 13, 2024 Aeos Robotic Digital Microscope, Product Code: PV010 Possibility of the robotic arm to drop more than 10cm from its original position after pressing t... Class II Aesculap Inc
May 7, 2024 CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... Class II Blue Belt Technologies, Inc
Apr 25, 2024 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not eng... Class II Synthes (USA) Products LLC
Apr 24, 2024 EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... Class II Olympus Corporation of the Americas
Apr 18, 2024 OES 4000 Hysteroscope, Model/Catalog Number: A4674A The required leakage test was not performed following of a re-work for a non-conformity. This cou... Class II Olympus Corporation of the Americas
Apr 3, 2024 InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile shea... Potential for distal end of the sheath to break off during a procedure. Class II Olympus Corporation of the Americas
Apr 1, 2024 OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 11... Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alar... Class I Philips Respironics, Inc.
Mar 26, 2024 BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbe... Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 26, 2024 BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and ... Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 26, 2024 BiPAP V30 Auto Ventilator, Part Number 1111178 Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... Class I Philips Respironics, Inc.
Mar 21, 2024 Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Arti... Coolant level in the cooling circuit drops below a certain level, this may result in a situation ... Class II Siemens Medical Solutions USA, Inc
Mar 20, 2024 Dr¿ger Perseus A500 Anesthesia Workstation Unexpected shutdown while operating on battery power. Class I Draeger Medical, Inc.
Mar 19, 2024 Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 19, 2024 Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... Class I Philips Respironics, Inc.
Mar 7, 2024 POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indica... Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... Class II Olympus Corporation of the Americas
Mar 7, 2024 POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indica... Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... Class II Olympus Corporation of the Americas
Mar 7, 2024 POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indica... Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... Class II Olympus Corporation of the Americas
Mar 4, 2024 X-Guide Handpiece Adaptor Sleeve 1, Model P010701 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... Class II X-NAV Technologies, LLC
Mar 4, 2024 X-Guide Handpiece Adaptor Sleeve 3, Model P010727 The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... Class II X-NAV Technologies, LLC
Mar 1, 2024 Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... Class II Olympus Corporation of the Americas

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.