Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96630

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 19, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Medline Sterile Water, USP, 100mL, REF RDI30295

Z-1705-2025
Recall number
Z-1705-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
963054 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10884389338230 (EA) 40884389338231 (CS), Lot Numbers: 23CJA159, 23GJA086, 23HJA080, 23JJA010, 23KJA047, 23LJA031, 23LJA089, 24AJA095, 24AJA157, 24CJA089, 24IJA004, 24IJA036, 24JJA164, 24KJA008, 24KJA051, 24KJA108.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 2 of 10

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

Z-1706-2025
Recall number
Z-1706-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
2519991 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10884389338247 (EA) 10884389338230 (CS), Lot Numbers: 23DJA038, 23DJA070, 23DJA114, 23EJA057, 23EJA128, 23EJA144, 23FJA110, 23GJA041, 23GJA118, 23GJA132, 23HJA033, 23IJA045, 23IJA052, 23IJA102, 23JJA103, 23JJA119, 23JJA144, 23LJA114, 24AJA025, 24AJA061, 24AJA180, 24BJA038, 24BJA092, 24BJA119, 24BJA158, 24CJA048, 24CJA117, 24CJA147, 24DJA010, 24HJA075, 24HJA178, 24KJA148.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 3 of 10

Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792

Z-1707-2025
Recall number
Z-1707-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10195327552350 (EA) 40195327552351 (CS), Lot Numbers: 24BBB747

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 4 of 10

Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438

Z-1708-2025
Recall number
Z-1708-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10889942529964 (EA) 40889942529965 (CS), Lot Numbers: 23KDB283

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 5 of 10

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.

Z-1709-2025
Recall number
Z-1709-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
822 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS), Lot Numbers: 23KBW508; 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS), Lot Numbers: 23KBB406; 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS), Lot Numbers: 23KBX338; 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS), Lot Numbers: 23KBX632; 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS), Lot Numbers: 23LDA746, 23LDA814, 23LDA218; 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS), Lot Numbers: 23LDA281, 23KDA001.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 6 of 10

Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535

Z-1710-2025
Recall number
Z-1710-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10653160144250 (EA) 40653160144251 (CS), Lot Numbers: 23JBU525

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 7 of 10

Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.

Z-1711-2025
Recall number
Z-1711-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
5200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

1) REF DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS), Lot Numbers: 23KBH040; 2) REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS), Lot Numbers: 23KBD401.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 8 of 10

Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A

Z-1712-2025
Recall number
Z-1712-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
2220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10195327514877 (EA) 40195327514878 (CS), Lot Numbers: 24BBJ082, 23KBH046, 23JBD137

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 9 of 10

Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K

Z-1713-2025
Recall number
Z-1713-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10195327385521 (EA)40195327385522 (CS), Lot Numbers: 23LME299

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

device · product 10 of 10

Medline procedure kits, labeled as: HAND, REF DYNJ902002J

Z-1714-2025
Recall number
Z-1714-2025
Initiated
March 19, 2025
Classification
Class II
Status
Ongoing
Quantity
159 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

UDI/DI 10195327516079 (EA) 40195327516070 (CS), Lot Numbers: 24ABC106, 23KBN892, 23JBV265

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Panama and Canada.