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Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm

Pemax Kunststoff GmbH · Model 12741.12364 · UDI-DI 04260462740357

PUI Prescription
0
510(k) clearances
471
Adverse events
54
Recalls
398
Facilities

Description

Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm

Recalls

DateFirmReason
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.
2026-09-09Medline Industries, LPReports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.