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Pennsylvania

Product Recalls in Pennsylvania

All product recalls affecting Pennsylvania.

Includes nationwide recalls (tagged “Nationwide”) and recalls with Pennsylvania in the distribution area.

Get alerts for Pennsylvania

Showing 441–460 of 34320 recalls

CONSTRUX Mini Ti Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

Low

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Neurotransmitters XL (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

GI Microbiome Profile Small (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

PSA Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Parasite Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Food Allergy Panel Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Women s Hormone Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

NAD Profile Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Diabetes Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

SIBO Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Fructose Intolerance Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Vitamin D2 and D3 Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Lyme Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

IVENIX Infusion System (Fresenius Kabi) – incorrect assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

High

FDANov 3, 2025Nationwide• Fresenius Kabi USA, LLC

Sperm Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Pet Allergy Test (GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden) – distribution without premarket approv... (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Gonorrhea Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Gut Microbiome Test Small (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Peptic Ulcer Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

3 in 1 STI Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

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