Z-2019-2026Class II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-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. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS... 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-2019-2026
- 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. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.
- Product code
- OFX General Purpose Dental Tray
- 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
- 2228 kits
- Distribution
- Worldwide distribution.
- Product codes and lots
- Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23JMB165; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23CMH103; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMH200; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMB495; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KMH108; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KME285; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23KMJ648; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 26BME013; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25JMC725; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25IMA571; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25HMC497; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25FMG199; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25EMB523; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25DMF918; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25CMH298; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24LMA598; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24JMH963; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMC899; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMD398; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24EME289; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24CMG724; Medline Kit Number/SKU DYNJ0660040S: UDI/DI each 10198459674907, UDI/DI case 40198459674908, Lot Number: 26BMD088; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23JBW720; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23EBR729; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23DBC424; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23CBD133; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23BBA368; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22LBG835; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22KBV773; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22IBB948; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24BBP259; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24ABS878; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23LBH114; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24GBC544; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24FBL453; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24EBH347; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25DBC120; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25CBF213; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24KBU249; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24IBQ393; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24HBN580; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25JBA224; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25HBQ050; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25GBN753; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25GBJ601; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBQ773; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBB129; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBE608; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBS231; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBF336; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBC263; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25JBL075.
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.