Z-2024-2026Class II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-19 / Open, Classified / root cause: sterility
Medline Industries, LP began a recall of Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK... on . FDA classified it as Class II and gives the reason as "During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin". As of , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-2024-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.
- Product code
- PPB Foley Catheter Kit (Excludes Hiv Testing)
- Reason for recall
- During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors must notify their customers and should include customer quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 2153 kits
- Distribution
- Worldwide distribution.
- Product codes and lots
- Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 23DBM600; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22JBM081; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22ABJ346; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO873; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO877; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21JBX107; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBE213; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBB024; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 22AMD386; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21LMC822; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21JMF409; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21IMC184; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21GMB555; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21EMD626; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21CMC668; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21AMB081; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23FMD067; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23EMB306; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23CMD967; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22KMB384; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22OBB494; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22BBT747; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22ABA711; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21LBG900; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21KBD492; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21EBS624; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21CBY739; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21ABL492; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22KBD211; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBX995; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBL500; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 24CBB115; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB463; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB461; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBT464; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBP591; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23EBS895; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23CBU007; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23ABE854; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22LBE910; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22JBP701; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22FBV579; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ713; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ714; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21LBD683; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21IBM004; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21FBJ190; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21EBE932; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21DBA613; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21CBI323; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22FBM378; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22EBE987; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22OBI162; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21KBF463; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21IBU411; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21GBJ251; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21DBU812.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2008-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2009-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2010-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2011-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2012-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2013-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2014-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2015-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2016-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2017-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2018-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2019-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2020-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2021-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2022-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2023-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2024-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2025-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2026-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2027-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2028-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2029-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2030-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2031-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2032-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2033-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2034-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2035-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2036-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2037-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2038-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.