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

29951–29975 of 40325

HighFDA (Devices)·Z-1831-2016·2016-06-08
Smiths Medical Recalls CADD Administration Sets with Flow Stop
Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.
Product
CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1836-2016·2016-06-08
Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk
Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.
Product
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1880-2016·2016-06-08
Ventlab STAT-Check Resuscitation Bag Recall Due to Non-Functional CO2 Indicators
Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.
Product
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2016·2016-06-08
Fujifilm ED-530XT Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.
Product
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2016·2016-06-08
Skytron EZ Slide Operating Table Recalled for Potential Slide Cap Detachment
Skytron is recalling 458 EZ Slide Operating Tables because incorrectly manufactured parts may cause the slide cap to detach, risking injury to patients or staff.
Product
EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2016·2016-06-08
Fujifilm ED-250XL5 Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Product
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2016·2016-06-08
Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.
Product
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1866-2016·2016-06-08
Integra MicroFrance Electrosurgical Instruments Recalled for Burn and Shock Risks
Integra LifeSciences is recalling 30,146 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.
Product
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1882-2016·2016-06-08
Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure
Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Product
Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1884-2016·2016-06-08
Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Product
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1850-2016·2016-06-08
Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
Product
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2016·2016-06-08
Natus Medical Recalls Replacement HEPA Filters for Sterile-Driers
Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.
Product
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1864-2016·2016-06-08
Fujifilm ED-450XL5 Endoscope Manual Correction for Infection Control
Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.
Product
Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1873-2016·2016-06-08
Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue
Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.
Product
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1845-2016·2016-06-08
Olympus Recalls Duodenoscopes for New Reprocessing Instructions
Olympus Corporation of the Americas is recalling TJF-160F and TJF-160VF duodenoscopes to provide new reprocessing instructions and a cleaning brush.
Product
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1872-2016·2016-06-08
Philips Brilliance 64 CT Systems Recalled for Software Mapping Error
Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.
Product
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1901-2016·2016-06-08
Exactech Recalls Two Novation Ceramic Hip Acetabular Cups
Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.
Product
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1876-2016·2016-06-08
Leica Novocastr Antibody Recalled for Stability Issues
Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.
Product
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1904-2016·2016-06-08
Exactech Recalls One Novation Femoral Stem Device for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.
Product
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1865-2016·2016-06-08
Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference
Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.
Product
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Category
Medical Device
Distribution
42 states
ModerateFDA (Devices)·Z-1840-2016·2016-06-08
Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
Product
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1838-2016·2016-06-08
Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues
Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.
Product
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2016·2016-06-08
Exactech Recalls Novation Femoral Stems Due to Premature Packaging
Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.
Product
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1903-2016·2016-06-08
Exactech Recalls One Novation Femoral Stem for Premature Packaging
Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.
Product
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1843-2016·2016-06-08
Medscience AllergiEnd Skin Test Applicators Recalled for Lack of Clearance
Medscience Inc is recalling AllergiEnd ST-9 skin test applicators and trays because they were marketed without FDA clearance.
Product
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator…
Category
Medical Device
Distribution
Distributed nationwide

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