Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

17726–17750 of 40287

HighFDA (Devices)·Z-1684-2020·2020-04-15
Radiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall
Radiometer Medical ApS is recalling ABL800 FLEX analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or sample loss.
Product
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1642-2020·2020-04-15
Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1688-2020·2020-04-15
Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias
Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.
Product
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1641-2020·2020-04-15
Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1681-2020·2020-04-15
Solta Medical Recalls Thermage Face Tips Due to Sparking and Burn Risk
Solta Medical is recalling Thermage Face Tip 3.0 units because sparking during use could cause skin burns.
Product
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1682-2020·2020-04-15
Change Healthcare Cardiology ECG Software Recalled for Heart Rate Estimation Errors
Change Healthcare Canada Company is recalling McKesson and Change Healthcare Cardiology ECG Management software due to potential inaccurate heart rate estimation in Sequential ECG format.
Product
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2020·2020-04-15
AAP Implantate Soft Tissue Retractor Recalled for Manufacturing Defect
AAP Implantate AG is recalling 7 units of soft tissue retractors because they may not be fully removed during manufacturing, potentially leaving debris in patients.
Product
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1643-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1689-2020·2020-04-15
Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise
Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, compromising sterility.
Product
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1638-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1660-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1647-2020·2020-04-15
Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1654-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-1674-2020·2020-04-15
Beckman Coulter MicroScan PROMPT Inoculation System-D Recalled for Incorrect Wands
Beckman Coulter is recalling 3,472 units of the MicroScan PROMPT Inoculation System-D because they contain incorrect prompt wands, which may cause inaccurate antimicrobial susceptibility test results.
Product
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1671-2020·2020-04-15
Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk
Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.
Product
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1653-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1669-2020·2020-04-15
Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1649-2020·2020-04-15
Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1663-2020·2020-04-15
Biomet Recalls Knee Spacer Molds Due to Insufficient Cleaning Process
Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning or inadequate process monitoring.
Product
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1655-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1652-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1673-2020·2020-04-15
Beckman Coulter LabPro Data Management System Software Update Recall
Beckman Coulter is recalling 177 LabPro Data Management Systems because a security update caused some computers to fail to restart, potentially delaying microbiology test results.
Product
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1691-2020·2020-04-15
Microbiologics QC Sets Recalled for Potential Mislabeling of Fungal Strains
Microbiologics Inc is recalling QC sets that may contain Candida utilis instead of the labeled Trichosporon dermatis.
Product
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1658-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Category
Medical Device
Distribution
49 states

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17726–17750 of 40287