Severity
Moderate
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UN
Reported: January 1, 2025 Initiated: November 6, 2024 #Z-0723-2025
MEDLINE INDUSTRIES, LP - Northfield issued this FDA Devices recall on January 1, 2025. Classified as Moderate severity (Class II). The recall was issued because: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expect…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0723-2025) was formally reported on January 1, 2025, with the manufacturer initiating the action on November 6, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and S… Distribution data in the federal record shows the product reached: US Nationwide. Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
Unknown
Related Recalls
6
6 from same agency
Product Description
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A
Reason for Recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Distribution
- US Nationwide. Canada.
- Location
- Northfield, IL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0723-2025 |
| Date reported | January 1, 2025 |
| Date initiated | November 6, 2024 |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Units affected | Not disclosed |
| Distribution | US Nationwide. Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU DYNJ69907A; 7) HEAD AND NECK PACK - 51597, SKU DYNJ81934B; 8) MAJOR CRANIOTOMY PACK, SKU DYNJ82007A; 9) SPINE PACK, SKU DYNJ82011A; 10) CRANIOTOMY MERCY STK 256, SKU DYNJ84068; 11) WMC UNIVERSAL NEURO PACK, SKU DYNJ84496A; 12) SPINE PACK LF, SKU DYNJ85830; 13) AHT SPINE PACK, SKU DYNJ903566D; 14) LAMINECTOMY SPINAL FUSION PACK, SKU DYNJ909364A; 15) DIEP, SKU DYNJ909472; 16) AMBULATORY SINUS, SKU DYNJ910292; 17) AMBULATORY SINUS, SKU DYNJ910292A. Recalled by MEDLINE INDUSTRIES, LP - Northfield.
Why was this product recalled? ▼
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0723-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0723-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).