Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Jan 17, 2020 LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... A security-only update was released via remote diagnostics on January 14, 2020 to customers with ... Class II Beckman Coulter Inc.
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot... The action is being taken due to an increase in complaints relating to the lower buccal tube slid... Class II Ormco/Sybronendo
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 16, 2020 COHERENCE Oncologist, Model Nos. 07333680 & 07351898 A potential safety issue arises when an offset calculation is followed by a filter operation; cor... Class II Siemens Medical Solutions USA, Inc
Jan 16, 2020 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ... Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... Class III Maquet Cardiovascular Us Sales, Llc
Jan 16, 2020 Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is a... The firm has identified factors which contributed to failures relating to thrombus formation and/... Class II Cook Inc.
Jan 16, 2020 Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ... Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th... Class III Maquet Cardiovascular Us Sales, Llc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-0552... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 -... The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status... Class II Abbott Point Of Care Inc.
Jan 15, 2020 FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-0... There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept... The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock pe... Class II Bard Peripheral Vascular Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International Inc
Jan 15, 2020 EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B There is the potential for various failures with the LOR (loss of resistance) syringes included i... Class II Arrow International 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.