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Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation Recalls

All product recalls associated with Terumo Cardiovascular Systems Corporation.

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Recall Summary

Total Recalls

1000

Past Year

888

Class I (Serious)

124

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 5161–5180 of 17593 recalls

Terumo HX2 Temperature System (Terumo) – Cleaning Protocol (2021)

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

Moderate

FDAApr 16, 2021Nationwide• Terumo Cardiovascular Systems Corporation

Compressed Oxygen (Grace Healthcare) – manufacturing deviation (2021)

cGMP deviations

Class IIModerate

FDAApr 15, 2021Nationwide• Grace Healthcare Medical, Inc

Illuminated Stepped Laser Probe (Dutch Ophthalmic) – Incorrect Expiration Label (2021)

Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

1...257 258259260 261...880

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Moderate

FDAApr 14, 2021Nationwide• Dutch Ophthalmic USA, Inc.

Radiometer ABL90 FLEX PLUS Analyzer (Radiometer) – Internal Clock Malfunction (2021)

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Moderate

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Access SARS-CoV-2 Antigen (Beckman Coulter) – False Negative Risk (2021)

specimens collected in transport media may result is false negative results when stored in certain conditions.

Moderate

FDAApr 14, 2021Nationwide• Beckman Coulter Inc.

Radiometer ABL90 FLEX Analyzer (Radiometer) – Internal Clock Malfunction (2021)

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Moderate

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

E3800 PC Units (Radiometer) – Internal Clock Malfunction (2021)

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Moderate

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Delflex Dialysis Solution (Fresenius) – labeling mix-up (2021)

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

Class IIModerate

FDAApr 14, 2021Nationwide• Fresenius Medical Care, North America

Organic Mr. Goodtime Bunny (Champlain Chocolate) – Undeclared Almonds (2021)

Undeclared Allergen

Product potentially contains undeclared almonds.

Class IIModerate

FDAApr 14, 2021CA, CT, MA +6 more• Champlain Chocolate Company

Basket Country Bunny ORG (Champlain Chocolate) - Undeclared Almonds (2021)

Undeclared Allergen

Product potentially contains undeclared almonds.

Class IIModerate

FDAApr 14, 2021CA, CT, MA +6 more• Champlain Chocolate Company

DONJOY UltraSling Pro (DJ Orthopedics) – Rivet Failure Risk (2021)

failed rivet at the chafe tab of arm sling.

Moderate

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DONJOY UltraSling Pro (DJ Orthopedics) – Rivet Failure Risk (2021)

failed rivet at the chafe tab of arm sling.

Moderate

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DONJOY UltraSling Pro (DJ Orthopedics) – Rivet Failure Risk (2021)

failed rivet at the chafe tab of arm sling.

Moderate

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

DONJOY UltraSling Pro (DJ Orthopedics) – Rivet Failure Risk (2021)

failed rivet at the chafe tab of arm sling.

Moderate

FDAApr 12, 2021Nationwide• DJ Orthopedics de Mexico S.A. de C.V. Carretera Libre Tijuana-Tecate 20230 Submetropoli El Florido Tijuana Mexico

G4G Low Carb Pancake Mix (Backcountry Mills) - Salmonella Risk (2021)

Salmonella

Potential to be contaminated with Salmonella

Class IIModerate

FDAApr 12, 2021TX• Backcountry Mills LLC

PERLA TL Lateral Connector (SpineArt) – Labeling Error (2021)

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Moderate

FDAApr 9, 2021Nationwide• SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland

Wintergreen & Alleviate Oils (Geo Essential) - Unspecified Issue (2021)

This recall involves GEO Wintergreen Organic Essential Oil and GEO Alleviate Organic Essential Oil Blend in amber glass bottles with black caps. The Wintergreen oil was sold in a 5 mL bottle and the Alleviate oil in a 15 mL bottle. The bottle's label displays the GEO logo, product name and the volume amount of the bottle. SKU 990181 can be found on the label above and to the left of the bar code of the Wintergreen essential oil and SKU 990305 on the label above and to the left of the bar code of the Alleviate essential oil.

Low

CPSCApr 8, 2021Nationwide• Geo Essential LLC, of Orem, Utah

Dutchmen Aspen Trail (Dutchmen) – Ramp Door Fastener Issue (2021)

Keystone RV Company (Keystone) is recalling 2020-2021 Dutchmen Aspen Trail 2760THS, 3250THS, and 3251THS trailers. The ramp door fasteners may be installed improperly causing them to strip.

Moderate

NHTSAApr 8, 2021Nationwide• DUTCHMEN

Groshong NXT ClearVue Catheter (Bard) – Connector Diameter Issue (2021)

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

Moderate

FDAApr 7, 2021Nationwide• Bard Access Systems Inc.

Groshong NXT ClearVue Catheter (Bard) – Connector Diameter Issue (2021)

Moderate

FDAApr 7, 2021Nationwide• Bard Access Systems Inc.