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Stradis Healthcare

Stradis Healthcare Recalls

All product recalls associated with Stradis Healthcare.

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Recall Summary

Total Recalls

1000

Past Year

590

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2261–2280 of 10391 recalls

PICC Kit (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Neonatal PICC Tray (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Max Barrier PICC Insertion Tray (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide

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• Stradis Healthcare

PHS Laceration Tray (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Central Line Insertion Tray (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

HCT 12 CC Syringe Kit (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Neonatal PICC Tray (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

HCT 50mL EVA Bags (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Cysto Setup Pack (Stradis) – Sterility Breach Risk (2022)

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Low

FDADec 15, 2022Nationwide• Stradis Healthcare

Jackson-Pratt Channel Drain (Cardinal Health) – Performance Issues (2022)

Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

Low

FDADec 14, 2022Nationwide• Cardinal Health 200, LLC

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Moderate

FDADec 12, 2022Nationwide• Siemens Healthcare Diagnostics Inc

Pepper Collection Gift Set (Something SA) – mold contamination (2022)

Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.

Class IIModerate

FDADec 12, 2022Nationwide• Something South African LLC

Cordless Window Shades Battery Packs (Dooya) – Fire Hazard (2022)

Fire/Burn Risk

This recall involves external lithium-ion battery packs used to power cordless window blinds. The recalled battery packs are white and are approximately10.5 inches long by approximately 1 inch in diameter. The recalled battery packs weigh about 10 ounces. The recalled battery packs have numerical codes on the white label on the side of the product. The following models and production lots are included in the recall. The model and production lots are printed on the battery. Retailer/Brands Model Name Marks on Label for Affected Batch 3 Day Blinds Alta PN 62203000 "2550mAh" with no PO# & "2550mAh" with PO# Range: 231866, 223081, 225204, 226910, 4200007528, 4200007887, 4200007888 Budget Blinds Blinds.com Blinds to Go The Shade Store Other Brands May Be Affected. Please check your product label MT03-0305-069003 "2550mAh"

High

CPSCDec 8, 2022Nationwide• Dooya Mechanic & Electronic Tech Co., of Ningbo, China

Adult Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

High

FDADec 7, 2022Nationwide• The Anspach Effort, Inc.

Pediatric Craniotome (Anspach) – Ball Bearing Failure (2022)

High

FDADec 7, 2022Nationwide• The Anspach Effort, Inc.

Large Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

High

FDADec 7, 2022Nationwide• The Anspach Effort, Inc.

Single-Use Packs (Johnson & Johnson) – Weld Protrusion (2022)

Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

Moderate

FDADec 7, 2022FL, IL, MN +5 more• Johnson & Johnson Surgical Vision, Inc.

Stay Informed

Stradis Healthcare Recalls

Recall Summary

PICC Kit (Stradis) – Sterility Breach Risk (2022)

Neonatal PICC Tray (Stradis) – Sterility Breach Risk (2022)

Max Barrier PICC Insertion Tray (Stradis) – Sterility Breach Risk (2022)

PHS Laceration Tray (Stradis) – Sterility Breach Risk (2022)

Central Line Insertion Tray (Stradis) – Sterility Breach Risk (2022)

HCT 12 CC Syringe Kit (Stradis) – Sterility Breach Risk (2022)

Neonatal PICC Tray (Stradis) – Sterility Breach Risk (2022)

HCT 50mL EVA Bags (Stradis) – Sterility Breach Risk (2022)

Cysto Setup Pack (Stradis) – Sterility Breach Risk (2022)

Jackson-Pratt Channel Drain (Cardinal Health) – Performance Issues (2022)

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

Pepper Collection Gift Set (Something SA) – mold contamination (2022)

Cordless Window Shades Battery Packs (Dooya) – Fire Hazard (2022)

Adult Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Pediatric Craniotome (Anspach) – Ball Bearing Failure (2022)

Large Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Single-Use Packs (Johnson & Johnson) – Weld Protrusion (2022)

Veritas Infusion Packs (Johnson & Johnson) – Weld Protrusion (2022)

Rotating Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

FUSION Dual Pump Packs (Johnson & Johnson) – Weld Protrusion (2022)