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Vehicle Safety

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

2,939 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
Aug 30, 2021 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 18, 2021 Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... Software versions may result in sporadic problems causing scanning workflow interruptions and un... Class II Siemens Medical Solutions USA, Inc
Aug 17, 2021 EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 A gluing step was not performed during the manufacturing of the affected device's insertion tube.... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 BF-P60 OES Bronchofiberscope, Model No. BF-P60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SO... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 BF-N20 OES Bronchofiberscope, Model No. BF-N20 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 16, 2021 BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... Class II Olympus Corporation of the Americas
Aug 10, 2021 Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for us... 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 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: si... 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, 115 IN-single use, for use with the Outloo... 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 Add-On Set-single use, for use with the Outlook Safety Infusion ... 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, 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.

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.