The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1397-2026·Announced 2026-02-25

Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration

Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with potential sterility compromise in medical devices warrant a score of 4 (Severe), as sterility assurance issues in surgical kits pose a direct risk to patient safety during procedures.

Plain-English summary

Medline Industries, LP is recalling 4,757 units of its convenience surgical kits. The recall includes 58 distinct kit models such as KIT PLASTIC ABDOMINOPLASTY, KIT PLASTIC ROTATIONAL FLAP, KIT SURG ONC MASTECTOMY, and BREAST PACK, among others, across model numbers ACC010499, DYKMBNDL117C, DYNJ0785310G, and many additional variants.

The recall is Class II and stems from calibration issues identified with equipment used to sterilize and package the devices. While all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

The affected products were distributed worldwide, including US nationwide distribution. The recall encompasses numerous lot numbers across all listed model numbers, with specific lot identifiers provided in the recall documentation.

Healthcare facilities and users who received any of the recalled kits should follow their organization's recall procedures. No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare providers with questions should contact Medline Industries, LP directly.

The recalled product

Product
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT…
Manufacturer
Medline Industries, LP
Category
Medical Device — Sterile Surgical Kits
Hazard
Affected units
4,757

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) ACC010499
  • UDI-DI: 10193489845709(each)
  • 40193489845700(case)
  • Lot Number: 25BDB702
  • 2) ACC010499
  • Lot Number: 25BDA228
  • 3) ACC010499
  • Lot Number: 25ADB705
  • 4) ACC010499
  • Lot Number: 24JDA650
  • 5) ACC010499
  • Lot Number: 24IDA403
  • 6) ACC010499
  • Lot Number: 23LDC086
  • 7) ACC010499
  • Lot Number: 23IDB182
  • 8) ACC010499
  • Lot Number: 23HDB786
  • 9) ACC010499
  • Lot Number: 21JDB530

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 42 products in this recall →

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