Z-2036-2026Class II
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL...
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. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2... 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-2036-2026
- 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. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
- Product code
- OKV Obstetrical Kit
- 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
- 7004 kits
- Distribution
- Worldwide distribution.
- Product codes and lots
- Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 22BBJ540; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21LBM539; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21IBX286; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21HBM832; Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725, UDI/DI case 40193489586726, Lot Number: 21KMD114; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 22FMI371; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 21IMD775; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23JBD782; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23HBY508; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23GBQ615; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBR984; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBD017; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23BBO048; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22JBI096; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22FBA057; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22CBA050; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21IBG464; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21GBJ471; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21EBA373; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21DBG514; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21ABD741; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23IBQ007; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23GBM279; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23EBT579; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23DBT199; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBP725; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBH452; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23ABR478; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22JBU430; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22IBM433; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22GBW568; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22EBG751; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBT428; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBE203; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22NBF066; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21KBZ291; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21IBL547; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21FBQ973; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21DBI879; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 26ABQ626; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25KBI185; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25JBK909; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25HBN871; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25FBI730; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25DBR613; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25BBP811; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24KBT890; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24HBT785; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24HBH475; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24FBP481; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24DBH874; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24CBG680; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23LBI949.
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
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