FDA · Medical device recall

MEDLINE ANTERIOR HIP… and 2 more products

Recall started June 5, 2026 · FDA enforcement report July 29, 2026 Class I

Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of…
Status: Ongoing
Distribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ.

Enforcement report date: July 29, 2026
Risk class: Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status: Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by: Medline Industries, LP
Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Distribution pattern: US: OH, CA, IL, IN, FL, SC, AZ, NJ.

What this record is about

A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.

“Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.”MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G, FDA enforcement report, 2026-07-29. The caption is the record's own words.

The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.

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FDA device name: General Surgery Tray

Distributed in (FDA's record): Arizona California Florida Illinois Indiana New Jersey Ohio South Carolina

3 products in this recall

MEDLINE ANTERIOR HIP…

Product: MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Quantity: 60 kits
Codes and lots: UDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430
Recall started: June 5, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: General Surgery Tray
Root cause (FDA): Under Investigation by firm
What the company told customers: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee 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. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Recall number: Z-2747-2026

MEDLINE convenience kits labeled as: 1) C-SECTION…

Product: MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Quantity: 56 kits
Codes and lots: 1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805.
Recall started: June 5, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: Cesarean Section Tray
Root cause (FDA): Under Investigation by firm
What the company told customers: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee 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. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Recall number: Z-2748-2026

MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT…

Product: MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J; 6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K; 7) TOTAL HIP, Medline Kit SKU DYNJ906665G; 8) TOTAL KNEE, Medline Kit SKU DYNJ906666J; 9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A; 10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A; 11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B; 12) TOTAL JOINT, Medline Kit SKU DYNJ909069B; 13) TOTAL KNEE, Medline Kit SKU DYNJ909070C; 14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B; 15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C; 16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534; 17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A; 18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B; 19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F; 20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D; 21) TOTAL KNEE, Medline Kit SKU DYNJ909643D; 22) TOTAL KNEE, Medline Kit SKU DYNJ909643F; 23) TOTAL JOINT, Medline Kit SKU DYNJ910002A; 24) TOTAL KNEE, Medline Kit SKU DYNJ910354A; 25) TOTAL HIP, Medline Kit SKU DYNJ910813; 26) ANTERIOR HIP, Medline Kit SKU DYNJ911083.
Quantity: 2301 kits
Codes and lots: Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25ELB079; Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25DLA930; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25IBN992; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25HBS205; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25DBH984; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25CBB436; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25ABR220; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 24LBI991; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBR847; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBE741; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 25ADA380; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 24KDA993; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA748; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA157; Medline Kit SKU DYNJ903493K, UDI/DI 10198459293122 (each) 40198459293123 (case), Kit Lot Number 25DDA444; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25GDA109; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25FDB471; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25EDB817; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25BDA465; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDB209; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDA032; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24KDB063; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 25ABU735; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 24LBU076; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25EBN666; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25DBF470; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25CBA048; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25FBH718; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25EBF688; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25DBO198; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25ABL694; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 24KBU683; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 25ABI346; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBR150; Medline Kit SKU DYNJ909068B, UDI/DI 10198459077364 (each) 40198459077365 (case), Kit Lot Number 24LBD242; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25EBM976; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25CBJ024; Medline Kit SKU DYNJ909069B, UDI/DI 10198459248375 (each) 40198459248376 (case), Kit Lot Number 25BBA740; Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25EBQ769; Medline Kit SKU DYNJ909070C, UDI/DI 10198459257490 (each) 40198459257491 (case), Kit Lot Number 25CBU372; Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 25ABF133; Medline Kit SKU DYNJ909071B, UDI/DI 10198459139321 (each) 40198459139322 (case), Kit Lot Number 24LBD821; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25FBA422; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25DBS695; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBV173; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25CBG902; Medline Kit SKU DYNJ909071C, UDI/DI 10198459257452 (each) 40198459257453 (case), Kit Lot Number 25BBN621; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 25ABV657; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO734; Medline Kit SKU DYNJ909534, UDI/DI 10195327389147 (each) 40195327389148 (case), Kit Lot Number 24LBO776; Medline Kit SKU DYNJ909534A, UDI/DI 10198459273209 (each) 40198459273200 (case), Kit Lot Number 25CBF686; Medline Kit SKU DYNJ909534B, UDI/DI 10198459527814 (each) 40198459527815 (case), Kit Lot Number 25JBN131; Medline Kit SKU DYNJ909640F, UDI/DI 10198459250057 (each) 40198459250058 (case), Kit Lot Number 25DBD310; Medline Kit SKU DYNJ909642D, UDI/DI 10198459250040 (each) 40198459250041 (case), Kit Lot Number 25HBR652; Medline Kit SKU DYNJ909643D, UDI/DI 10198459250064 (each) 40198459250065 (case), Kit Lot Number 25DBB386; Medline Kit SKU DYNJ909643F, UDI/DI 10198459392603 (each) 40198459392604 (case), Kit Lot Number 25HBU964; Medline Kit SKU DYNJ910002A, UDI/DI 10198459073335 (each) 40198459073336 (case), Kit Lot Number 25DBH861; Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25DBF544; Medline Kit SKU DYNJ910354A, UDI/DI 10198459089282 (each) 40198459089283 (case), Kit Lot Number 25CBM051; Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBU686; Medline Kit SKU DYNJ910813, UDI/DI 10198459123276 (each) 40198459123277 (case), Kit Lot Number 25CBF765; Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25DBK837; Medline Kit SKU DYNJ911083, UDI/DI 10198459242335 (each) 40198459242336 (case), Kit Lot Number 25CBN099.
Recall started: June 5, 2026
Voluntary or mandated: Voluntary: Firm initiated
Device type: Orthopedic Tray
Root cause (FDA): Under Investigation by firm
What the company told customers: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee 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. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Recall number: Z-2749-2026

This recall among the others

FDA's enforcement report came 54 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
MEDLINE INDUSTRIES: 140 other recalls or notices on this site in the three years before this one (from July 30, 2023).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement reports, recall numbers Z-2747-2026, Z-2748-2026, Z-2749-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record

FDA recall record Z-2747-2026, July 29, 2026. "MEDLINE ANTERIOR HIP… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-2747-2026/ (as of the day it was built).

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