CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report
Medline Robotic-lf recalled by Medline Industries
Medline Industries is recalling Medline Robotic-lf, distributed in California. The recall was initiated on 21 Jan 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-1358-2020
- FDA event ID
- 84908
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2020
- FDA classified
- 25 Feb 2020
- Reported
- 4 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Jan 2020 | Recall initiated by company | |
| 25 Feb 2020 | Classified by FDA | +35 days |
| 4 Mar 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Where it was distributed
California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103
Questions about this recall
Is Medline Robotic-lf recalled?
Yes. Medline Industries recalled Medline Robotic-lf on 21 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1358-2020.
Why was it recalled?
The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Which lots are affected?
REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Where was it sold?
California only. No governmental, Canadian or Mexican consignees. TORRANCE MEMORIAL MEDICAL 3105 LOMITA BLVD TORRANCE CA 905055108 HOAG MEMORIAL HOSPITAL 1 HOAG DR NEWPORT BEACH CA 926634162 OWENS/MINORVMI TEM (65) 5125 ONTARIO MILLS PKWY ONTARIO CA 917645103
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 21 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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