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Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom Recalls

All product recalls associated with Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom.

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Recall Summary

Total Recalls

1000

Past Year

742

Class I (Serious)

175

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 241–260 of 11123 recalls

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

FDASep 16, 2025Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

Skin MD Body Acne Cleanser (Private Label Skin Care) – benzene contamination (2025)

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Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

Micronized BPO Gel Cleanser (Private Label Skin Care) – benzene contamination (2025)

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

Benzaderm BPO Cleanser (Private Label Skin Care) – benzene contamination (2025)

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

Benzoyl Peroxide Acne Treatment (Private Label) – Benzene Contamination (2025)

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

Artisan of Skin Benzoyl Peroxide Gel (Private Label Skin Care) – benzene contamination (2025)

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

Edunn Clarity BP Treatment Cleanser (Private Label Skin Care) – benzene contamination (2025)

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Class IIModerate

FDASep 12, 2025CA, GA• Private Label Skin Care Inc.

iNSitu Bipolar Hip System (Theken) – Sterile Barrier Risk (2025)

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

FDASep 11, 2025Nationwide• Theken Companies LLC

Ashvins HEYEX 2 (MedicalCommunications) – Measurement Inaccuracy (2025)

Potential that the measured value may be smaller than the actual area.

FDASep 9, 2025Nationwide• MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany

CellMek SPS System (Beckman Coulter) – Incorrect Volume Listing (2025)

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

FDASep 8, 2025Nationwide• Beckman Coulter, Inc.

Pinocchio Catering Aged Kimchi Mackerel (Lee K of NY) – Undeclared Allergens (2025)

Undeclared Milk

Product contains undeclared milk and shrimp

FDASep 8, 2025NJ, NY• Lee K of NY Inc.

C-Rex UNO Goniotomy Instrument (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

FDASep 6, 2025Nationwide• Iantrek Inc.

Cyclopen Cyclodialysis System (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

FDASep 6, 2025Nationwide• Iantrek Inc.

Deep Premium Sambhar Mix (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Val Papdi (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Snake Gourd (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Tapioca Diced (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Arvi (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC

Deep Ponk With Tangy Sev (Chetak) – Salmonella Risk (2025)

Product tested positive Salmonella .

FDASep 5, 2025Nationwide• CHETAK NEW YORK LLC