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 |
|---|---|---|---|---|
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 19, 2020 | EMPOWR Partial Knee Peg Drill; Model: 800-06-008. | There have been issues experienced with the peg preparation steps, specifically drilling of the F... | Class II | Encore Medical, LP |
| Jun 19, 2020 | SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemost... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. | There have been issues experienced with the peg preparation steps, specifically drilling of the F... | Class II | Encore Medical, LP |
| Jun 19, 2020 | SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... | Quality Control results were not properly evaluated for QC failures. | Class II | Abbott Gmbh & Co. KG |
| Jun 19, 2020 | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. ... | Sterile introducer sheath set manufactured under one lot with different expiration dates. | Class II | Argon Medical Devices, Inc |
| Jun 19, 2020 | SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Inject... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Cata... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Nu... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Por... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 0080... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Ca... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 19, 2020 | PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 21319... | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. De... | Class II | Becton Dickinson & Company |
| Jun 18, 2020 | Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- R... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 18, 2020 | Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxy... | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediat... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Jun 18, 2020 | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rub... | Class II | Mueller Sports Medicine, Inc |
| Jun 18, 2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm s... | Class II | Synthes, Inc. |
| Jun 18, 2020 | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for th... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 18, 2020 | Phillips Charging Station, Product #: 989803191021 - Product Usage: This char... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapi... | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Chembio Diagnostics, Inc |
| Jun 18, 2020 | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module... | A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its a... | Class II | Philips North America, LLC |
| Jun 18, 2020 | Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number... | High rate of galling of one threaded component. | Class II | Anjon Holdings |
| Jun 17, 2020 | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 33557... | The firm received reports from customer that the Regard Migrating Indicator shown malfunctions an... | Class II | Resource Optimization & Innovation LLC |
| Jun 17, 2020 | LoFric Origo, Nelaton, 16in, FR10 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | LoFric Origo, Tiemann, 16in, FR14 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to... | An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility... | Class II | FHC, Inc. |
| Jun 17, 2020 | LoFric Origo, Tiemann, 16in, FR12 urinary catheters | Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a ... | Class II | Wellspect HealthCare (Division of DENTSPLY IH AB) |
| Jun 17, 2020 | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA ... | The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman C... | Class II | Beckman Coulter Biomedical GmbH |
| Jun 16, 2020 | BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Sets, REF: A120-160CYFRV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A100-163XES | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-125XSE | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Sets, REF: A120-160C2YRV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Set, REF: A120-161CYF | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A100-163XSFL | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-161XYB | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-160GCFA | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-160XPS | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Set, REF: A120-160CRV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | CMExpress Microbore Set, REF: A120-160C | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset with Filter, REF: A100-163XESF | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A100-163XESV | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
| Jun 16, 2020 | BodyGuard Microset, REF: A120-160XYSF | Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... | Class I | CME America, LLC |
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.