PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported January 1, 2025

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOP

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 produ…

Recall #
Z-0720-2025
Affected scope
6467 kits
Initiated
November 6, 2024
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Medline Industries, LP - Northfield recalled Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982… - a moderate-severity action.

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982… was recalled by Medline Industries, LP - Northfield in January 1, 2025. Reason: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-t…. Check the official notice for the remedy. Verify recall #Z-0720-2025 with the FDA Devices before acting.

The recall

Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-t….

Moderate
severity level
Class II
classification
January 1, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0720-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-0720-2025
Date reported January 1, 2025
Date initiated November 6, 2024
Recalling firm Medline Industries, LP - Northfield
Firm location Northfield, IL
Affected scope 6467 kits
Distribution US Nationwide. Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0720-2025) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370. Recalled by Medline Industries, LP - Northfield. Units affected: 6467 kits.
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-0720-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Canada..
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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This recall: FDA Devices, reported January 1, 2025. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026