Browse Device Recalls

48 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 48 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 48 FDA device recalls.

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DateProductReasonClassFirm
Jul 30, 2020 CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or ... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
Jul 30, 2020 CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medicatio... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
Jul 30, 2020 CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infus... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
Jul 30, 2020 CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
Jul 30, 2020 CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medication... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
Jul 30, 2020 CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or ... Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusi... Class II CME America, LLC
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
Jun 16, 2020 BodyGuard Microset, REF: A120-112XSFK 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 w/ 0.2 mic filter and lower y-site with female luer, REF: ... 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: A120-003XS2YV 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: A100-163XE90S 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: A100-164XESF 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 Male Luer Connectors, REF: A100-163XEBF Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 Standard BodySet with Needleless Connectors, REF: A120-125XS 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: A100-163XSL 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: A120-161XYBS 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: A120-161XPSV 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 and Manual Priming Valve, REF: A120-112XSFV 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: A120-160XSFE Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard set with Female Luer, REF: A120-003XSN 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 w/ 0.2 mic filter and lower y-site with female luer, REF: ... 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: A120-161C 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: A120-160XSFK Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Jun 16, 2020 BodyGuard BodySet, REF: A120-160SAS 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: A120-160X2YB 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 Female Luer, REF: A120-160XPSN 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: A120-161XPS Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from min... Class I CME America, LLC
Feb 27, 2020 CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue numbe... The wall charger may not properly charge the infusion pump battery. Class II CME America LLC
Jan 14, 2020 BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 i... The filter installed onto the tube set may have the incorrect pore size. Class II CME America, LLC
Jan 7, 2020 CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG ... Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster ... Class I CME America, LLC
Sep 16, 2019 BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Pr... When using a specific tubing set with infusion pump system, may result in under deliver of fluids. Class I CME America, LLC
Jan 16, 2015 BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, ... CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for ... Class II 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.