Calibration of sterilization equipment for surgical kits (Z-2093-2026) — one firm accounts for a tenth of the records
A recall began for surgical convenience kits after the firm identified calibration problems in the equipment used to sterilize and package them, with potential effect on sterility assurance. The recalling firm alone accounts for a tenth of the records held here.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmMedline Industries, LP
- ReasonMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- DistributionWorldwide - US Nationwide distribution.
- Recall initiated2026-01-07
Key points
- The reason is not a defect in the kits but calibration problems in the equipment used to sterilize and package them.
- All products passed validated cycles, yet sterility assurance could be affected: the inability to verify is itself the reason.
- Of the 1,408 records this site holds as of 2026-09-04, the largest single firm accounts for 141 (10.0%), against 33 (2.3%) for second place.
- Illinois leads the state field at 183 (13.0%) largely because that firm sits there, which is not evidence of more recalls in that state.
- A high record count reflects catalogue breadth and records splitting by model number rather than a proven excess of problems.
1The process, not the product, is the reason
The reason here is not a defect found inside the kits. It is a calibration problem in the equipment used to sterilize and package them. The record acknowledges that every product passed through validated cycles, and then says the calibration issues could still affect sterility assurance. Nothing was confirmed unsterile. What cannot be said is that it was definitely sterile.
This is the same shape as the missing service documentation in the previous article: the inability to verify is itself the reason.
2One firm, a tenth of the records
Counted by recalling firm, the largest single firm accounts for 141 records, a tenth of everything. Second place holds 33. Illinois leads the state field partly because that is where this firm sits. Illinois has a lot of recalls is not a reading these numbers support. The state field carries a firm location, so a firm with many records lifts the count for its state.
3Why the concentration
No reason is recorded, though the structure suggests one. A firm handling a large catalogue of medical supplies has more product varieties to be covered. And as an earlier article showed, records split by model number. One problem in a process, spreading across dozens of products, becomes dozens of records on its own. A high count reflects breadth of catalogue and how records divide, not a proven excess of problems.
4The eight fields, side by side
These articles have read recall records one field at a time. What follows sets out what each field says and does not say. The denominator is the 1,408 records this site holds as of 2026-09-04.
| Field | What it records | Distribution across those same 1,408 |
|---|---|---|
| Class | An estimate of how severe potential harm is | Class I, 319 (22.7%) |
| Product type | Food, drugs or devices | Devices, 779 (55.3%) |
| Status | Ongoing, or finished | Ongoing, 1,382 (98.2%) |
| Distribution | Where it was sent, not where it was sold | Nationwide mentioned, 1,054 (74.9%) |
| Quantity | Units subject to recall, in units that vary | 1,029 distinct expressions, 62 blank |
| State | A location tied to the recalling firm, not to harm | No state identified, 169 (12.0%) |
| Dates | Two of them, the start and the publication | Median interval 44 days, longest 5,616 |
| Firm | Who is recalling | Largest single firm, 141 (10.0%) |
Not one of these fields answers on its own whether a recall concerns you. Class gives severity, quantity gives scale, state gives a firm address.
Getting closer means working from what identifies the product, its name, model, UPC code and dates, with distribution and dates alongside. These records describe beginnings and subjects in detail, and endings and outcomes hardly at all. That, too, is part of the shape of recall information.
Why it matters
A recall can rest on a process that cannot be verified rather than on a defect found. Counts by firm reflect catalogue breadth and the splitting of records by model number rather than a firm having more problems, and counts by state inherit the same distortion. Anyone aggregating public data has to establish first what the unit of a record actually is.
FAQ
Was a defect found in the products?
Why does one firm have so many records?
Does Illinois have more recalls?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2093-2026