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

16801–16825 of 40124

HighFDA (Devices)·Z-2636-2020·2020-07-22
Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects
Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.
Product
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2619-2020·2020-07-22
Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits
Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2626-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing incomplete bone formation.
Product
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2020·2020-07-22
Skeletal Kinetics Recalls SKAFFOLD FLOW Bone Void Filler Kits
Skeletal Kinetics is recalling SKAFFOLD FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.
Product
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2634-2020·2020-07-22
Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits
Skeletal Kinetics is recalling Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.
Product
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2591-2020·2020-07-22
Shimadzu Recalls Three Trinias DAP Meters for Tolerance Issues
Shimadzu Medical Systems is recalling three Trinias DAP Meters because they were found to be outside of tolerance. The devices are used in interventional procedures.
Product
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2590-2020·2020-07-22
DJO Nylatex Wraps Recalled for Missing Latex Warning Labels
DJO, LLC is recalling Nylatex wraps used with Intelect and V-Sonic devices because they lack appropriate latex warning labels.
Product
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2638-2020·2020-07-22
Neocis Dental Chairside Splints Recalled for Potential Mislabeling
Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints due to potential mislabeling. The affected products are used in dental implantation surgery.
Product
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2637-2020·2020-07-22
Neocis Dental Chairside Splints Recalled for Potential Mislabeling
Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units distributed nationwide.
Product
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2639-2020·2020-07-22
Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging
Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.
Product
DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2550-2020·2020-07-22
Access Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits
Access Scientific LLC is recalling 1,710 Powerwand XL kits due to incorrect catheter length labels. The error may cause treatment delays or user annoyance.
Product
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2504-2020·2020-07-15
CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cages Due to Fracturing
CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2501-2020·2020-07-15
CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2489-2020·2020-07-15
Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns
Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.
Product
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2502-2020·2020-07-15
CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracture Reports
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2503-2020·2020-07-15
CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing
CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
Product
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2491-2020·2020-07-15
Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues
Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.
Product
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2528-2020·2020-07-15
TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.
Product
PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2497-2020·2020-07-15
Ra Medical Systems Recalls DABRA Laser Due to Software Issue
Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.
Product
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The…
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2519-2020·2020-07-15
Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk
Kentec Medical is recalling 70 ENFit feeding tubes because the plastic tethered closure cap may fracture, potentially delaying care or causing unnecessary radiation exposure.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2492-2020·2020-07-15
Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues
Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.
Product
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2529-2020·2020-07-15
TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.
Product
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2520-2020·2020-07-15
Kentec Medical Recalls ENFit Enteral Feeding Tubes Due to Cap Fracture Risk
Kentec Medical is recalling 170 ENFit enteral feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Product
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2487-2020·2020-07-15
Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns
Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to a lack of assurance of sterility.
Product
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
Category
Medical Device
Distribution
Distributed nationwide

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16801–16825 of 40124