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

16576–16600 of 40287

ModerateFDA (Devices)·Z-2905-2020·2020-09-02
Neurovision Cobra EMG Endotracheal Tubes Recalled for Insulation Softening
Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.
Product
Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2889-2020·2020-09-02
BD SafetyGlide Syringes Recalled for Incorrectly Printed Scale Markings
Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.
Product
BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2875-2020·2020-09-02
Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.
Product
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2874-2020·2020-09-02
Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.
Product
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2902-2020·2020-09-02
Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening
Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.
Product
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2886-2020·2020-09-02
Match Point System surgical instrument recalled due to incorrect procedure side labeling
The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.
Product
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2877-2020·2020-09-02
OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling
OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2876-2020·2020-09-02
OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling
OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1510-2020·2020-08-26
CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility
CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.
Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Category
Medical Device
Distribution
2 states
CriticalFDA (Drugs)·D-1511-2020·2020-08-26
CareFusion Chlorhexidine Applicators Recalled for Non-Sterility
CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.
Product
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2821-2020·2020-08-26
Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables
Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.
Product
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2828-2020·2020-08-26
NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling
Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.
Product
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2805-2020·2020-08-26
PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery
Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.
Product
PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2816-2020·2020-08-26
DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues
Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.
Product
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2807-2020·2020-08-26
Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues
Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.
Product
Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2818-2020·2020-08-26
Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment
Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.
Product
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2815-2020·2020-08-26
Whirlpool Recalls Powered Air-Purifying Respirators Due to Loose Headband Risk
Whirlpool is recalling 528 powered air-purifying respirators because rivets may be mis-assembled, allowing the face shield to detach and fall on the user.
Product
PAPR (Powered Air-Purifying Respirator) - Model# WLPAPR20W1
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2817-2020·2020-08-26
Golden Technologies Lift Chair Recalled for Suspected Poor Weld
Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.
Product
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2806-2020·2020-08-26
Argon Medical Devices Recalls ClosureFast Micro Introducer Sheath Sets
Argon Medical Devices is recalling 1,000 units of ClosureFast Micro Introducer Sheath Sets because the sterile products were manufactured under one lot with different expiration dates.
Product
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2814-2020·2020-08-26
Olympus Smart Stapes Protheses Piston Recalled for Mislabeled Outer Carton
Olympus is recalling 21 units of Smart Stapes Protheses Piston because the outer carton was mislabeled, potentially containing a different model.
Product
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2825-2020·2020-08-26
CareFusion Alaris EtCO2 Module Recall for Dim LED Display Segments
CareFusion 303, Inc. is recalling Alaris EtCO2 Module Model 8300 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.
Product
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2826-2020·2020-08-26
CareFusion Alaris SpO2 Module Recall for Dim LED Display Segments
CareFusion 303, Inc. is recalling Alaris SpO2 Modules because the LED display may have dim segments, potentially affecting the visibility of infusion or patient monitoring values.
Product
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2830-2020·2020-08-26
Pharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads
Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads because the device was incorrectly registered as a Class I device and requires a 510(k) submission.
Product
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2808-2020·2020-08-26
Chembio DPP Micro Reader Recalled for Performance Issues
Chembio Diagnostics is recalling 126 DPP Micro Reader kits because the FDA revoked their Emergency Use Authorization due to performance issues.
Product
Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2813-2020·2020-08-26
Olympus Recalls Mislabeled Smart Stapes Protheses Piston Medical Devices
Olympus Corporation of the Americas is recalling 16 units of Smart Stapes Protheses Piston due to outer carton mislabeling.
Product
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Category
Medical Device
Distribution
4 states

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16576–16600 of 40287