Food, drugs, devices › Medline Industries Inc
Device recall: Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
Medline Industries Inc (Northfield, IL) initiated this device recall on 21 Jan 2020; FDA lists 2 product records under event 84908, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 12 Jan 2023. Initiation: voluntary: firm initiated. Medline Industries Inc has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries Inc, Northfield, IL.
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."
Distribution
"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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1357-2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 | 122 | Class II | Terminated | 4 Mar 2020 |
| Z-1358-2020 | Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350 | 122 | Class II | Terminated | 4 Mar 2020 |
Context
Other enforcement events for Medline Industries Inc
All 61 events for Medline Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.