Stryker Corporation Recalls

FDASep 12, 2023MD, TN• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Fairfield Gourmet Food Corp. d/b/a David s Cookies ,28 Industrial Road, Fairfield NJ 07004has initiated a recall of Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g) plastic package (i.e.) Clamp shell 8 package per case, LOT # BS23212 (Manufactured on July, 31, 2023) because of MISLABELED / UNDECLARED ALLERGENS (Peanuts)

1...263 264265266 267...1884

Page 265 of 1884Next

Class IIModerate

FDASep 13, 2023AL, AR, CA +17 more• Fairfield Gourmet Food Corp d/b/a David's Cookies

RayCare (RaySearch) – Document Visibility Issue (2023)

An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.

Low

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

DxI 9000 Analyzer (Beckman Coulter) – Barcode Presentation (2023)

The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

High

FDASep 12, 2023Nationwide• Beckman Coulter, Inc.

Kentucky Trailer XL-12 (Kentucky Trailer) – Refrigeration Problem (2023)

Fire/Burn Risk

Kentucky Trailer Manufacturing (KTM) is recalling certain 2019-2023 (KTSV) XL-12 trailers equipped with Carrier Transicold Supra 950, 950MT, and 960 refrigeration units. The centrifugal clutch may overheat and break apart.

NHTSASep 12, 2023Nationwide• KENTUCKY TRAILER

Lemon Raspberry Scone (Fine Sconehenge) – Undeclared Egg (2023)

Undeclared allergen; egg

FDASep 12, 2023CA, IN, NV• The Kitchen Garden Co, LLC

Chocolate Chip Scone (Fine Sconehenge) – Undeclared Egg (2023)

Undeclared allergen; egg

FDASep 12, 2023CA, IN, NV• The Kitchen Garden Co, LLC

Lemon Blueberry Scone (Fine Sconehenge) – Undeclared Egg (2023)

Undeclared allergen; egg

FDASep 12, 2023CA, IN, NV• The Kitchen Garden Co, LLC

English Scone (Fine Sconehenge) – Undeclared Egg (2023)

Undeclared allergen; egg

FDASep 12, 2023CA, IN, NV• The Kitchen Garden Co, LLC

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

FDASep 12, 2023Nationwide• Olympus Corporation of the Americas

Cranberry Orange Scone (Fine Sconehenge) – Undeclared Egg (2023)

Undeclared allergen; egg

FDASep 12, 2023CA, IN, NV• The Kitchen Garden Co, LLC

Spetzler-Malis Forceps (Stryker) – Expiration Labeling (2023)

An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

Low

FDASep 11, 2023Nationwide• Stryker Corporation

Sapphire Infusion Pumps (Eitan Medical) – Air Detection Failure (2023)

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

Very High

FDASep 11, 2023Nationwide• EITAN MEDICAL LTD 29, Yad Kharutsim Netanya Israel

LittleOak Goat Milk Formula (Little Oak) – Regulatory Issue (2023)

No pre-market notification and Mixing instructions not in ounces

Class IIModerate

FDASep 11, 2023AL, AK, AR +43 more• The Little Oak Company Ltd

LittleOak Infant Formula (Little Oak) – Regulatory Issue (2023)

No pre-market notification and Mixing instructions not in ounces

Class IIModerate

FDASep 11, 2023AL, AK, AR +43 more• The Little Oak Company Ltd

Centricity Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

FDASep 8, 2023Nationwide• GE Healthcare

Universal Viewer Workflow Manager (GE Healthcare) – Exam Launch Issue (2023)

FDASep 8, 2023Nationwide• GE Healthcare

F2-01 Patient Monitor (GE Medical) – Data Communication Interruption (2023)

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.