Device recall: Medline Sterile Water, USP, 100mL, REF RDI30295
Class II FDA enforcement event 96630. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II, in the words of FDA
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 19 Mar 2025. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 96630 has 10 product records. The first FDA enforcement report date is 7 May 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1705-2025 | Medline Sterile Water, USP, 100mL, REF RDI30295 | 963054 units | Class II | Ongoing | 7 May 2025 |
| Z-1706-2025 | Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296 | 2519991 units | Class II | Ongoing | 7 May 2025 |
| Z-1707-2025 | Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792 | 30 units | Class II | Ongoing | 7 May 2025 |
| Z-1708-2025 | Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 | 240 units | Class II | Ongoing | 7 May 2025 |
| Z-1709-2025 | Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A. | 822 units | Class II | Ongoing | 7 May 2025 |
| Z-1710-2025 | Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535 | 120 units | Class II | Ongoing | 7 May 2025 |
| Z-1711-2025 | Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A. | 5200 units | Class II | Ongoing | 7 May 2025 |
| Z-1712-2025 | Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A | 2220 units | Class II | Ongoing | 7 May 2025 |
| Z-1713-2025 | Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K | 30 units | Class II | Ongoing | 7 May 2025 |
| Z-1714-2025 | Medline procedure kits, labeled as: HAND, REF DYNJ902002J | 159 units | Class II | Ongoing | 7 May 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 10Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-1705-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96630. https://recallregister.com/fda/ii/96630/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- What quantity of product is in FDA event 96630?
- The event has 10 product records. The first record gives this quantity:
963054 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.