CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Sterile Betadine recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Sterile Betadine, distributed nationwide in the US. The recall was initiated on 3 Nov 2023 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-0530-2024
- FDA event ID
- 93395
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Nov 2023
- FDA classified
- 11 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 3 Nov 2023 | Recall initiated by company | |
| 11 Dec 2023 | Classified by FDA | +38 days |
| 20 Dec 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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
STERILE BETADINE, REF DYNDA1998
Where it was distributed
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Nationwide CaliforniaConnecticutFloridaIowaLouisianaMassachusettsNew YorkPennsylvania
Questions about this recall
Why was it recalled?
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Which lots are affected?
UDI/DI 40889942651062 (case), 10889942651061 (each), Lot numbers: 2023042190, 2022101090, 2022081590, 2022041390, 2022031090, 2022011290, 2021100490
Where was it sold?
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
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.
Other products in this recall event
6 other products · FDA event 93395This product is part of a recall event; the main page for the event is Sterile Pvp Solution recalled by MEDLINE INDUSTRIES, LP.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile Pvp Solution recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile Povidone recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile PVP recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile Prep Stick recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Sterile Pvp Sln Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide | |
| CLASS II | Pvp Solution Sing Strl recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Sterility | Nationwide |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |