Sacaleches manual Hegen

This is a hand-operated pump with no motor tubing, but Hegen does not state whether the pump body includes a backflow barrier that keeps expressed milk from reaching any non-cleanable part, and the diaphragm and valve materials are not named.

No 510(k) clearance number is published for this pump, and it is not stated anywhere whether the pump is a single-user or a multi-user device — the most important sharing and resale caution for a breast pump goes unaddressed.

The polymers used in the pump's milk- and mouth-contact parts are not identified anywhere, and there is no statement on bisphenols — BPA, BPS or BPF — or on phthalates for this pump.

No flange or breast-shield size is stated for this pump, no alternative sizes or inserts are offered, and no fitting guidance or lactation-consultant help is published to let a parent measure and choose.

Pump parts are sold individually so a worn handle or component can be swapped out, but no replacement interval is given for any part, and there is no guidance on which sterilization methods — boiling, steam, UV or dishwasher — the pump is rated for.

Milk is expressed straight into Hegen bottles rather than transferred between containers, and individual pump parts are sold as replacements, but the bottle and valve materials are not named and no replacement schedule is given for the valve or diaphragm.

We queried the full CPSC recall corpus — 9,944 records spanning June 1973 to August 2026 — and found no recall filed against Hegen USA in any role, at any date. The same corpus returns hundreds of records for comparable juvenile-product classes, so the clean result reflects the brand's absence from the register rather than a gap in coverage.

Hegen names no safety standard, no testing laboratory and no certification for this pump; the brand's US pages carry brand-story material only, with no testing or certification content of any kind.

Pump parts such as the SoftSqround handle are sold individually, so a worn component can be replaced rather than the whole pump. The disclosure stops short on the product itself — the materials list, the country of manufacture and any warranty term for the pump are not published.