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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.