CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
CMEAmerica BodyGuard Wall Charger recalled
CME America is recalling CMEAmerica BodyGuard Wall Charger, distributed in Illinois, Kansas, Missouri. The recall was initiated on 27 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0305-2021
- FDA event ID
- 85479
- Recalling firm
- CME America, Golden, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Feb 2020
- FDA classified
- 29 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2020 | Recall initiated by company | |
| 29 Oct 2020 | Classified by FDA | +245 days |
| 4 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The wall charger may not properly charge the infusion pump battery.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00
Where it was distributed
U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".
Questions about this recall
Why was it recalled?
The wall charger may not properly charge the infusion pump battery.
Which lots are affected?
Catalog NO. 151-143XL LOT NO. 2019-0364
Where was it sold?
U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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