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Draeger Medical Systems, Inc.

Draeger Medical Systems, Inc. Recalls

All product recalls associated with Draeger Medical Systems, Inc..

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Recall Summary

Total Recalls

309

Past Year

Class I (Serious)

Most Recent

Oct 2025

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 41–60 of 309 recalls

Draeger Medical Systems, Inc.: Draeger Softbed Resuscitaire and/or Birthing Room Warmer ...

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

FDAMay 16, 2023Nationwide• Draeger Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, RE...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-1...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide

1 234 5...16

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• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile ...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F,...

There is a potential that valve assemblies will not open. preventing fluid from draining.

FDAApr 22, 2023Nationwide• Merit Medical Systems, Inc.

Draeger Medical Systems, Inc.: Draeger Infinity CentralStation (ICS), centralized monito...

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Draeger Medical Systems, Inc.: Draeger Infinity M300 and M300+, for use with the ICS to ...

FDAApr 5, 2023Nationwide• Draeger Medical Systems, Inc.

Soft Hands Alcohol Antiseptic 80% (Jarman's) – Methanol Contamination (2023)

Chemical Contamination: FDA testing found Presence of methanol

Class IHigh

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Alcohol Antiseptic 80% (Jarman's) – Methanol Contamination (2023)

Chemical Contamination: FDA testing found Presence of methanol

Class IHigh

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Isopropyl Alcohol Antiseptic 75% (Jarman's) – Methanol Contamination (2023)

CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Class IIModerate

FDAMar 27, 2023Nationwide• Jarman's Midwest Cleaning Systems, Inc.

Merit Medical Systems, Inc.: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E0...

Custom sheath Introducer contains incorrect needle size

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

Paradise Grills Outdoor Kitchens – Fire hazard (2023)

Fire/Burn Risk

This recall involves First Generation Paradise Grills Outdoor Kitchens. They can have cabinets, sinks, refrigerators, and other features such as LED lighting, Tiki Huts, commercial grills, granite and other additional options. The recalled models are the GX-3, GX-4, GX-5, GX-6, GX-7, GX-8, GX-9, GX-10, GX-11 GX12 and GX14, Tahiti, Fiji, Tropicana, Aruba 6 and Aruba 8. The model name is listed on the sales agreement.

CPSCFeb 16, 2023Nationwide• Paradise Grilling Systems Inc., of Ocoee, Florida

Buprenorphine Transdermal System (AVEVA) – Substance Impurity Concerns (2023)

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

Class IIILow

FDAFeb 15, 2023Nationwide• AVEVA Drug Delivery Systems, Inc.

Merit Medical Systems, Inc.: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE...

Product that was built for design verification testing was inadvertently distributed to customers.

FDAFeb 15, 2023Nationwide• Merit Medical Systems, Inc.

Buprenorphine Patch (AVEVA) – impurity specification failure (2023)

Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

Class IIILow

FDAFeb 15, 2023Nationwide• AVEVA Drug Delivery Systems, Inc.

R & D Systems, Inc.: R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack He...

For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.

FDANov 7, 2022Nationwide• R & D Systems, Inc.

Merit Medical Systems, Inc.: CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610...

Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

FDAAug 3, 2022AL, AK, AZ +40 more• Merit Medical Systems, Inc.

Bard Access Systems, Inc.: Intraosseous needle and driver. Catalog/Device Name: ...

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

FDAJun 20, 2022Nationwide• Bard Access Systems, Inc.

R & D Systems, Inc.: Quantikine IVD Erythropoietin Human Serum Controls for us...

The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body designation, British Standards Institution number 2797 (BSI-2797) for product inserts 750095.28 and 750095.29. The erroneous label CE2797 were in the IFU insert revision 750095.28 for the 408 affected lots that were shipped. No product was packed with erroneous insert revision 750095.29. Since the product is currently CE marked as a Class I - self-certified product under the EU In Vitro Diagnostics Directive, the Notified Body designation should not be specified. As part of the corrective action, the firm has notified the customers who received the products with erroneous labeling, and is conducting the replacements with the correct product insert containing the Insert Revision 750095.30

FDAJun 14, 2022Nationwide• R & D Systems, Inc.

Draeger Medical Systems, Inc.: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers...

The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

FDAMay 20, 2022DE, IN• Draeger Medical Systems, Inc.