All Product Recalls

Browse through 1,551 product recalls and safety alerts. Filter by hazard level, status, or search for specific products.

HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Mycoplasma Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 23 units of its Mycoplasma test on November 3, 2025. The recall occurred due to distribution without premarket approval, classified as Class II. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues

Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.

Orthofix U.S.
Labeling contains
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Medium

GET TESTED INTERNATIONAL AB recalled 16 units of Food Intolerance Test Medium on November 3, 2025. The recall stems from distribution without premarket approval. Consumers should stop use immediately and follow provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Mycotoxin Panel Test

GET TESTED INTERNATIONAL AB recalled 2 units of its Mycotoxin Panel Test on November 3, 2025. The recall follows distribution without necessary premarket approval. Consumers must stop using the product immediately and follow the provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls GI Microbiome Profile Small

GET TESTED INTERNATIONAL AB recalled one GI Microbiome Profile Small on November 3, 2025. The recall stems from distribution without premarket approval. This recall affects healthcare providers and patients across the United States.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Food Allergy Panel Test

GET TESTED INTERNATIONAL AB recalled three units of its Food Allergy Panel Test (IgE) on November 3, 2025. The recall follows distribution without premarket approval. The company advises immediate cessation of use and provides further instructions for patients and healthcare providers.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Menopause Tests Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 184 units of Menopause (FSH) 2 Tests on November 3, 2025. This recall occurred due to distribution without premarket approval or clearance. Healthcare providers and patients must stop using the tests immediately and follow recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

GET TESTED INTERNATIONAL AB Issues Chlamydia Test Recall

GET TESTED INTERNATIONAL AB recalled five Chlamydia Tests on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

GET TESTED INTERNATIONAL AB
Distribution without
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HIGHFDA DEVICE

Fresenius Kabi Recalls Infusion System Due to Assembly Error

Fresenius Kabi USA recalled 12,075 infusion pump administration sets on November 3, 2025. The recall stems from incorrect assembly that poses a serious risk of patient injury. Healthcare providers and patients should stop using the devices immediately.

Fresenius Kabi USA
Incorrect assembly
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