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

33201–33225 of 40325

ModerateFDA (Devices)·Z-1418-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 73 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.
Product
Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1436-2015·2015-04-22
NobelReplace Dental Implants Recalled for Packaging Material Contamination
Nobel Biocare is recalling 23 units of NobelReplace CC PMC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1423-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling 23 dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1430-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling specific dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1415-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling 17 dental implant units because packaging material may leave a sticky substance on the implant surfaces.
Product
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1427-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 594 units of NobelReplace CC NP dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
NobelReplace CC NP 3.5x13mm, Article No. 36702.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1422-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 72 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.
Product
NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1431-2015·2015-04-22
Nobel Biocare Recalls Dental Implants Due to Packaging Material Issue
Nobel Biocare is recalling specific NobelReplace dental implants because packaging material may leave a sticky substance on the implant surfaces.
Product
NobelReplace CC RP 4.3x13mm, Article No. 36708.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1411-2015·2015-04-22
Biomet 3i Recalls Discolored OSSEOTITE Dental Implants
Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.
Product
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1328-2015·2015-04-15
Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1334-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1329-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1335-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1331-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1377-2015·2015-04-15
Carestream CS 8100 X-ray Device Recalled for Unexpected Head Descent
Carestream Health is recalling CS 8100 panoramic X-ray units because the device head may descend unexpectedly. Approximately 3,110 units were distributed worldwide.
Product
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic…
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1330-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1332-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1333-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1404-2015·2015-04-15
Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems
Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.
Product
Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1392-2015·2015-04-15
Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1386-2015·2015-04-15
Intuitive Surgical Recalls da Vinci Si Monitor Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
Product
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1389-2015·2015-04-15
Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for the drape to tear.
Product
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1400-2015·2015-04-15
Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.
Product
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1393-2015·2015-04-15
Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci Si Surgical System disposable accessory kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1390-2015·2015-04-15
Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits
Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a risk of tearing.
Product
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Category
Medical Device
Distribution
1 state

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33201–33225 of 40325