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