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Sky Medical Supplies and Equipments LLC

Sky Medical Supplies and Equipments LLC Recalls

All product recalls associated with Sky Medical Supplies and Equipments LLC.

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Recall Summary

Total Recalls

1000

Past Year

726

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 3221–3240 of 11124 recalls

SARS-CoV-2 Antibody Test (Sky Medical) – Authorization Violation (2021)

Distributed COVID test kits without emergency use authorization.

Moderate

FDAJan 19, 2021Nationwide• Sky Medical Supplies and Equipments LLC

Ethicon Endo-Surgery Device (Stryker) – Regulatory Clearance Missing (2021)

Product was distributed without receiving regulatory clearance.

Moderate

FDAJan 19, 2021Nationwide• Stryker Sustainability Solutions

Golden Lentil Soup (Amy's) – Egg Contamination (2021)

Canadian Food Inspection Agency tested product with results of 1.4 ppm of egg.

Class IIModerate

FDA

1...160 161162163 164...557

Page 162 of 557Next

Jan 18, 2021

CA, CT, FL +14 more

• Amys Kitchen Inc

Cinnamon Walnut Coffee Cake (Nueske) – Undeclared Allergens (2021)

Undeclared Gluten

Coffee cake may contain undeclared wheat, egg, milk, and walnuts.

Class IIModerate

FDAJan 18, 2021AR, CA, CO +20 more• Nueske Applewood Smoked Meat, Inc

Blueberry Blizzard Coffee Cake (Nueske) – Undeclared Allergens (2021)

Undeclared Gluten

Coffee cake may contain undeclared wheat, egg, and milk.

Class IIModerate

FDAJan 18, 2021AR, CA, CO +20 more• Nueske Applewood Smoked Meat, Inc

Steam in Bag Butternut Brussels Pecan (Publix) - Listeria risk (2021)

Listeria

Cubed butternut squash used in the preparation of three of the firm's products is potentially contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 14, 2021Nationwide• Publix Super Markets, Inc.

Steam in Bag Green Bean Butternut Squash (Publix) - Listeria risk (2021)

Listeria

Cubed butternut squash used in the preparation of three of the firm's products is potentially contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 14, 2021Nationwide• Publix Super Markets, Inc.

Publix Steam in Bag Butternut Medley (Publix) – Listeria Risk (2021)

Listeria

Cubed butternut squash used in the preparation of three of the firm's products is potentially contaminated with Listeria monocytogenes.

Class IIModerate

FDAJan 14, 2021Nationwide• Publix Super Markets, Inc.

ENROUTE Transcarotid Stent (Silk Road) - Tip Detachment Risk (2021)

Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

Moderate

FDAJan 13, 2021AZ, CA, CO +40 more• Silk Road Medical Inc

LED Headlight Bulb (HIKARI) - Configuration Safety Issue (2021)

Ningbo shuwu Import & Export Co.,ltd (Ningbo) is recalling certain aftermarket Hikari headlight bulbs, LED-V39-R3 and RS-R models (in configurations H1, H4, H7, H11, H13, 9004, 9005, 9006, 9007, 9012) sold through Amazon.com. These bulbs may create excessive glare or brightness for oncoming traffic. As such, these bulbs fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

Moderate

NHTSAJan 12, 2021Nationwide• HIKARI TECHNOLOGY

Natus EDS CSF Drainage (Natus) - Pyrogen Test Failure (2021)

The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Moderate

FDAJan 12, 2021Nationwide• Natus Manufacturing Limited Ida Business Park Glenbrack Road Galway Ireland

Frozen Tuna Ground Meat (Khee Trading) – Histamine Levels (2021)

Potential elevated levels of histamine.

Class IIModerate

FDAJan 11, 2021CA, IL, MN +2 more• Khee Trading, Inc.

WMTS Telemetry Receiver (Nihon Kohden) - Data Transfer Problem (2021)

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Moderate

FDAJan 8, 2021AL, AZ, AR +43 more• Nihon Kohden America Inc

SARS-CoV-2 Reagents (BD) - Mislabeling Risk (2021)

Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.

Low

FDAJan 7, 2021Nationwide• Becton Dickinson & Co.

Nitrofurantoin Capsules (American Health) – Dissolution Failure (2021)

Failed Dissolution Specifications

Class IIModerate

FDAJan 7, 2021Nationwide• American Health Packaging

Klein's Cookies and Cream Bulk Ice Cream (Weis Markets) – Metal Contamination (2021)

Ice Cream product may contain metal (foreign objects).

Class IIModerate

FDAJan 5, 2021DE, IN, MD +5 more• Weis Markets, Inc., Ice Cream Division

Weis Quality Cookies and Cream Ice Cream – Metal Contamination (2021)

Ice Cream product may contain metal (foreign objects).

Class IIModerate

FDAJan 5, 2021DE, IN, MD +5 more• Weis Markets, Inc., Ice Cream Division

Klein's Vanilla Ice Cream (Weis Markets) – Metal Contamination (2021)

Ice Cream product may contain metal (foreign objects).

Class IIModerate

FDAJan 5, 2021DE, IN, MD +5 more• Weis Markets, Inc., Ice Cream Division

Nelsons Graham Slam Bulk Ice Cream (Weis Markets) – Metal Contamination (2021)

Ice Cream product may contain metal (foreign objects).

Class IIModerate

FDAJan 5, 2021DE, IN, MD +5 more• Weis Markets, Inc., Ice Cream Division

Balloon Catheter (Olympus) - Package Seal Defect (2021)

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Moderate

FDAJan 4, 2021Nationwide• Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan