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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 341–360 of 1,000 recalls

Class IIITerminated

Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.

Biomedical Polymers, Inc.

The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

September 18, 2019 · DeviceView details →

Class IIITerminated

Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.

Biomedical Polymers, Inc.

The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

September 18, 2019 · DeviceView details →

Class IIITerminated

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Roche Diagnostics Operations, Inc.

Due to low Quality Control recovery and invalid Calibration.

September 11, 2019 · DeviceView details →

Class IIITerminated

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

Roche Diagnostics Operations, Inc.

Due to low Quality Control recovery and invalid Calibration.

September 11, 2019 · DeviceView details →

Class IIITerminated

Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

CooperSurgical, Inc.

The touchpad may not work properly after cleaning.

September 5, 2019 · DeviceView details →

Class IIITerminated

FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

Biofire Defense

The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

August 20, 2019 · DeviceView details →

Class IIITerminated

LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.

CooperSurgical, Inc.

Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.

August 19, 2019 · DeviceView details →

Class IIITerminated

EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent administration of liquid medication and nutrition to humans through the patient s mouth.

Baxter Healthcare Corporation

Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.

August 13, 2019 · DeviceView details →

Class IIITerminated

Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.

Randox Laboratories Ltd.

Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.

July 25, 2019 · DeviceView details →

Class IIITerminated

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Cincinnati Sub-Zero Products LLC, a Gentherm Company

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

July 19, 2019 · DeviceView details →

Class IIITerminated

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

Randox Laboratories Ltd.

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

July 12, 2019 · DeviceView details →

Class IIITerminated

LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.

LivaNova USA Inc.

Perfusion tubing pack was packaged with the incorrect cuvette.

July 3, 2019 · DeviceView details →

Class IIITerminated

Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

Clariance Inc

Potential for the polyaxial screw to become disassembled during implant.

July 1, 2019 · DeviceView details →

Class IIITerminated

EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

Baxter Healthcare Corporation

EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

June 27, 2019 · DeviceView details →

Class IIITerminated

TAPSYSTEM Model 2A, REF 8002A

Cardiocommand Inc.

There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.

June 24, 2019 · DeviceView details →

Class IIITerminated

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Randox Laboratories, Limited

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

June 10, 2019 · DeviceView details →

Class IIITerminated

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

Polymer Technology Systems, Inc.

The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

June 7, 2019 · DeviceView details →

Class IIITerminated

Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

Polymer Technology Systems, Inc.

The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

June 7, 2019 · DeviceView details →

Class IIITerminated

inLight Medical LED Pads used with Polychromatic light technology system

Inlightened Partners LLC

LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.

June 4, 2019 · DeviceView details →

Class IIITerminated

ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

Abbott Laboratories

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

May 24, 2019 · DeviceView details →

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