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

28001–28025 of 40233

ModerateFDA (Devices)·Z-0836-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(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-0829-2017·2016-12-28
Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(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-0787-2017·2016-12-28
FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling
Vygon MFG, Inc. is recalling 31,500 AMS-651 Microbore extension sets because the package displays an incorrect priming volume.
Product
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0896-2017·2016-12-28
Busse recalls surgical instrument trays containing recalled gloves
Busse Hospital Disposables is recalling surgical instrument trays that contained recalled Covidien Devon Light Gloves.
Product
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0821-2017·2016-12-28
Stanmore Implants Recalls Tibial Components Due to Packaging Puncture
Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.
Product
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0382-2017·2016-12-28
Teleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization
Teleflex Medical is recalling Flexi Nozzle Long sprayers because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
FLEXI NOZZLE LONG, 10 Boxes of 25 units each 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0895-2017·2016-12-28
Busse Breast Pack Surgical Instrument Tray Recalled for Labeling Update
Busse Hospital Disposables is recalling Breast Pack Surgical Instrument Trays because they contained gloves subject to a labeling update.
Product
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0845-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling a limited number of Low Profile 30-degree abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(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-0883-2017·2016-12-28
Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects
Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.
Product
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0843-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(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-0874-2017·2016-12-28
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
8450-009-040 4.0MM 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-0867-2017·2016-12-28
Synthes VA Implant Rack Recalled for Incorrect Assembly
Synthes (USA) Products LLC is recalling 31 units of the VA Implant Rack for the Compact Distal Radius System because incorrect assembly could cause screws to touch the surface beneath the rack.
Product
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0783-2017·2016-12-28
Ultroid Mobile Generator and Sterile Probes Recalled for Quality System Failures
Ultroid Technologies is recalling 62 mobile generator units and sterile probes because they were not manufactured under required quality system controls.
Product
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-0894-2017·2016-12-28
Busse Carpal Tunnel Surgical Packs Recalled Due to Labeling Update
Busse Hospital Disposables is recalling Carpal Tunnel Packs because they contained Devon Light Gloves subject to a labeling update.
Product
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0864-2017·2016-12-28
Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.
Product
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0859-2017·2016-12-28
Biomet 3i Low Profile Abutment Quickbridge Recall for Unsealed Pouches
Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE 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
LowFDA (Devices)·Z-0879-2017·2016-12-28
OrthoPediatrics PediNail Cortical Screw Recalled for Dimensional Discrepancy
OrthoPediatrics is recalling 22 PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screws because they measure 50mm instead of the labeled 48mm.
Product
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-0860-2017·2016-12-28
Biomet 3i Low Profile Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 108 low profile abutments because some pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT HEXED 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
LowFDA (Devices)·Z-0832-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling specific 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 30¿ ABUTMENT 4.1MM(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
LowFDA (Devices)·Z-0838-2017·2016-12-28
Biomet 3i Low Profile Dental Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 123 units of Low Profile Dental Abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN 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
LowFDA (Devices)·Z-0853-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 191 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(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
LowFDA (Devices)·Z-0856-2017·2016-12-28
Biomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING 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
LowFDA (Devices)·Z-0850-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 204 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE ONE-PIECE 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
LowFDA (Devices)·Z-0847-2017·2016-12-28
Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 175 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(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
LowFDA (Devices)·Z-0840-2017·2016-12-28
Biomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.
Product
BIOMET 3i CERTAIN LOW PROFILE 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

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28001–28025 of 40233