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Showing 6861–6880 of 8389 results

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STRATAFIX Spiral Suture (Ethicon) – component mix-up (2022)

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

FDAMar 24, 2022IN• Ethicon, Inc. Us

IN.PACT AV Balloon Catheter (Medtronic) – packaging sterility (2022)

Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

FDAMar 23, 2022Nationwide• Medtronic Vascular, Inc.

TearCare SmartHubs (Sight Sciences) – device clearance (2022)

Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.

FDAMar 23, 2022Nationwide• Sight Sciences, Inc.

IN.PACT Admiral Balloon Catheter (Medtronic) – packaging sterility (2022)

Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

FDAMar 23, 2022Nationwide• Medtronic Vascular, Inc.

ACS Surgical Kits (American Contract Systems) – sterilization issue (2022)

Product was sterilized with a higher than specification EO concentration.

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

ACS Spine and Lumbar Packs (American Contract Systems) – sterilization issue (2022)

Product was sterilized with a higher than specification EO concentration.

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

ACS IR - Angio Pack (American Contract Systems) – sterilization issue (2022)

Product was sterilized with a higher than specification EO concentration.

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

ACS Cath Lab Pack (American Contract Systems) – sterilization issue (2022)

Product was sterilized with a higher than specification EO concentration.

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

ACS Lap Chole Pack (American Contract Systems) – sterilization issue (2022)

Product was sterilized with a higher than specification EO concentration.

FDAMar 22, 2022Nationwide• American Contract Systems, Inc.

Prevantics Swabs and Swabsticks (Windstone Medical Packaging) – Drug Product Issue (2022)

Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products.

FDAMar 21, 2022FL, GA, PA +1 more• Windstone Medical Packaging, Inc.

Ultrasonic Gastrovideoscope GF-UC140P-AL5 (Olympus) – Infection Control Risk (2022)

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

FDAMar 18, 2022Nationwide• Olympus Corporation of the Americas

Panther Fusion GBS Assay Cartridges (Hologic) – False Negative Risk (2022)

Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.

FDAMar 18, 2022AR, CA, CT +18 more• Hologic, Inc

da Vinci Sureform Stapler (Intuitive Surgical) – Tissue Pushout Events (2022)

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.

FDAMar 17, 2022Nationwide• Intuitive Surgical, Inc.

MUSE Cardiology System (GE Healthcare) – Software Measurement Loss (2022)

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

FDAMar 16, 2022Nationwide• GE Healthcare, LLC

LetsGetChecked Blood Sample Kit (LetsGetChecked) – Mislabeled Samples (2022)

Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

FDAMar 16, 2022Nationwide• LetsGetChecked Inc.

ZEISS miLOOP Lens Device (Carl Zeiss) – High Friction Risk (2022)

High friction of the slider can cause the device to stick, or not move as intended.

FDAMar 16, 2022AL, AZ, AR +29 more• Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany

PrisMax System (Baxter Healthcare) – Software Anomaly (2022)

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.

FDAMar 15, 2022Nationwide• Baxter Healthcare Corporation

PrisMax System (Baxter Healthcare) – Software Anomaly (2022)

This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.

FDAMar 15, 2022Nationwide• Baxter Healthcare Corporation

ATLAS Stim Headbox (Neuralynx) – Device Exemption Problem (2022)

Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.

FDAMar 14, 2022Nationwide• Neuralynx Inc

Cub 2 Bed Canopy (Sensory Medical) – Warning Update (2022)

Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.

FDAMar 14, 2022Nationwide• Sensory Medical Inc

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