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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,969 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 2,969 FDA device recalls in PA.

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DateProductReasonClassFirm
Aug 10, 2021 OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infus... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infus... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with th... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Saf... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administ... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with th... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for u... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 10, 2021 PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safet... Leakage of the pump set within the cassette portion of the pump sets, potential for delays in adm... Class II B. Braun Medical, Inc.
Aug 3, 2021 Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number:... Packaging seal defect may allow a breach of the package sterile barrier and result in patient inf... Class II Olympus Corporation of the Americas
Jul 26, 2021 Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, ... Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jul 26, 2021 Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jul 26, 2021 Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15... Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jul 26, 2021 Trilogy Evo Universal, Product number DS2000X11B Two software issues have been identified related to pressure increase in the device: The first is... Class II Philips Respironics, Inc.
Jun 30, 2021 LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spinal system devices. Class II Aesculap Implant Systems LLC
Jun 30, 2021 Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser ... Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded ... Class II Olympus Corporation of the Americas
Jun 30, 2021 RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spinal system devices. Class II Aesculap Implant Systems LLC
Jun 30, 2021 Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Ar... Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/... Class II Siemens Medical Solutions USA, Inc
Jun 29, 2021 Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowle... Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the br... Class II Oakworks Inc
Jun 25, 2021 Infusomat Space Volumetric Pump Administration Set, Product Code 490100 There is a potential for the Anti-free flow clip of the administration set to be inverted which m... Class II B. Braun Medical, Inc.
Jun 14, 2021 DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 9, 2021 Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, me... Expired adhesive used as an electrical insulation barrier and as a secondary retention bond faile... Class II Olympus Corporation of the Americas
May 27, 2021 ARTIS pheno- angiography systems developed for single and biplane diagnostic ... Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... Class II Siemens Medical Solutions USA, Inc
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. int... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-0715... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. intr... Marketed without a 510K Class II Arrow International Inc
May 19, 2021 Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Co... Marketed without a 510K Class II Arrow International Inc
Apr 20, 2021 Multitom RAX with software version VF10 Siemens identified two issues, In some cases, it is possible to perform an image acquisition alth... Class II Siemens Medical Solutions USA, Inc
Apr 16, 2021 PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... Class II Aesculap Implant Systems LLC
Apr 16, 2021 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medica... Class II Aesculap Implant Systems LLC
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Us... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Us... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 16, 2021 Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product... Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... Class II Draeger Medical, Inc.
Apr 15, 2021 T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -... Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending su... Class II Flower Orthopedics Corporation
Apr 15, 2021 Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit... Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the t... Class II Vygon U.S.A.
Apr 6, 2021 BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Materi... Certain devices were built with motor assemblies that could contain non-conforming plastic materi... Class II Philips Respironics, Inc.
Apr 6, 2021 BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Numbe... Certain devices were built with motor assemblies that could contain non-conforming plastic materi... Class II Philips Respironics, Inc.
Apr 6, 2021 BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Numb... Certain devices were built with motor assemblies that could contain non-conforming plastic materi... Class II Philips Respironics, Inc.
Apr 6, 2021 BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Mat... Certain devices were built with motor assemblies that could contain non-conforming plastic materi... Class II Philips Respironics, Inc.
Apr 6, 2021 BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Numb... Certain devices were built with motor assemblies that could contain non-conforming plastic materi... Class II 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.