Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Set, REF: A120-160C
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IStandard BodySet with Needleless Connectors, REF: A120-125XS
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard set with Female Luer, REF: A120-003XSN
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Sets, REF: A120-161C
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Sets, REF: A120-160C2YRV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Sets, REF: A120-160CYFRV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-160GCFA
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-125XSE
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-003XS2YV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A100-163XSL
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A100-163XE90S
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Filter, REF: A100-164XESF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Filter, REF: A120-160XSFE
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Set, REF: A120-161CYF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass ICMExpress Microbore Set, REF: A120-160CRV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-160X2YB
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-161XPSV
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset with Filter, REF: A100-163XESF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-161XYBS
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-161XYB
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-160XYSF
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A100-163XSFL
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-112XSFK
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-160XSFK
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
- 2020-07-22FDA-DeviceCME America, LLCClass IBodyGuard Microset, REF: A120-161XPS
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
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