Drape, Surgical, Antimicrobial

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-05-07Open, ClassifiedProcess control

  Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

  Medline 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.

• 2026-04-17Open, ClassifiedComponent change control

  Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

  Unapproved design changes to the products outside of the 510(k) clearance.

• 2026-02-17Open, ClassifiedUnder Investigation by firm

  Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

  Medline 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.

• 2025-09-04Open, ClassifiedProcess control

  Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

  Surgical drape packs may have open seals, which may compromise the sterility of the product.

• 2025-04-17Open, ClassifiedUnder Investigation by firm

  Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239

  There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

• 2025-01-17Open, ClassifiedProcess control

  Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

  Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

• 2024-10-23Open, ClassifiedUnder Investigation by firm

  Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

  It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

• 2024-09-06Open, ClassifiedUnder Investigation by firm

  Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

• 2023-08-03Open, ClassifiedNonconforming Material/Component

  Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B

  Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

• 2023-02-10Open, ClassifiedUnder Investigation by firm

  Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063

  The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.