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

27976–28000 of 40233

ModerateFDA (Devices)·Z-0873-2017·2016-12-28
Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Product
8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0780-2017·2016-12-28
PerkinElmer RoboRack Tips Recalled for Inaccurate Pipetting Volumes
PerkinElmer is recalling 20ul Clear RoboRack Tips used with the JANUS Automated Workstation because they may dispense volumes 50-100% lower than specified.
Product
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0824-2017·2016-12-28
Stanmore Implants Recalls DF Coated Integral Shaft and Stem Components
Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.
Product
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0771-2017·2016-12-28
Teleflex Recalls RUSCH Pocket PAC Intermittent Catheter Kits Due to Labeling Error
Teleflex Medical is recalling RUSCH Pocket PAC Intermittent Catheter Kits because they are labeled with expiration dates that exceed the validated shelf life.
Product
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0772-2017·2016-12-28
AngioDynamics Recalls Percutaneous Introducer Sets Due to Detachment Risk
AngioDynamics is recalling 162 boxes of Stiffened Micro-Introducer Kits because the rotating luer may detach from the dilator hub during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0820-2017·2016-12-28
Stanmore Tibial Component Fixed Hinge Recall Due to Pouch Puncture
Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured packaging.
Product
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0384-2017·2016-12-28
Teleflex Medical Recalls LMA MADgic Atomization Devices for Spray Defect
Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0841-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 525 low-profile dental implant abutments because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0888-2017·2016-12-28
Owens & Minor Recalls Medi Choice Arm Slings Due to Surface Contamination
Owens & Minor is voluntarily recalling specific lots of Medi Choice Arm Slings due to surface contamination identified through customer complaints.
Product
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0822-2017·2016-12-28
Stanmore Implants Recalls Punctured Femoral Shaft Components
Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.
Product
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0381-2017·2016-12-28
Teleflex Recalls LMA MADomizer Sprays Due to Inadequate Atomization
Teleflex Medical is recalling LMA MADomizer devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0844-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling a limited number of dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0385-2017·2016-12-28
Teleflex Recalls LMA MADett Endotracheal Tubes for Inadequate Anesthesia Delivery
Teleflex Medical is recalling LMA MADett endotracheal tubes because they may fail to atomize medication, potentially causing inadequate anesthesia.
Product
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0849-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i, LLC is recalling 160 units of Low Profile Abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0386-2017·2016-12-28
Teleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect
Teleflex Medical is recalling LMA MADdy topical anesthesia sprays because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0882-2017·2016-12-28
Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals
Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.
Product
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0383-2017·2016-12-28
Teleflex Medical Recalls Flexi Nozzle Short Sprayers for Anesthesia Delivery
Teleflex Medical is recalling Flexi Nozzle Short sprayers because they may deliver a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0872-2017·2016-12-28
Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Product
8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0868-2017·2016-12-28
Stryker Recalls Sterile Minimally Invasive Surgery Burs Due to Corrosion
Stryker is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because they may exhibit signs of corrosion.
Product
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0826-2017·2016-12-28
Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect
Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.
Product
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0823-2017·2016-12-28
Stanmore Implants Recalls Punctured Femoral Stem Components
Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.
Product
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2017·2016-12-28
Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.
Product
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0858-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Unsealed Packaging
Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0863-2017·2016-12-28
Biomet 3i Low Profile Abutment Titanium Retaining Screw Recall
Biomet 3i is recalling 1,633 Low Profile Abutment Titanium Retaining Screws because a limited number of product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0825-2017·2016-12-28
Philips Ingenia MR-OR Recalled for Potential Touch Current Exposure
Philips is recalling nine Ingenia MR-OR units due to a possibility that patients or users may be exposed to a very small level of touch current.
Product
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple…
Category
Medical Device
Distribution
2 states

How to read this listing

Filters

27976–28000 of 40233