Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

Clear
DateProductReasonClassFirm
Dec 19, 2023 Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ... Class II OriGen Biomedical, Inc.
Jan 28, 2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class III OriGen Biomedical, Inc.
Jun 24, 2019 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile E... The firm has become aware that they have distributed product that was expired. Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications:... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indicati... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... The catheter failed the endotoxin testing. Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: ... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: ... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications:... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 2, 2017 The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter wit... Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has ha... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Mar 30, 2015 OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO... Potential for clear extension tube to separate from the hub, which could result in blood loss and... Class I OriGen Biomedical, Inc.
Mar 30, 2015 REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO... Potential for clear extension tube to separate from the hub, which could result in blood loss and... Class I OriGen Biomedical, 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.