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

26576–26600 of 40233

HighFDA (Devices)·Z-2305-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2017·2017-06-14
Arrow PICC Kit Recall Due to Needlestick Injury Risk
Arrow International is recalling specific PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2017·2017-06-14
ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
Product
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2303-2017·2017-06-14
Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk
Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2241-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2223-2017·2017-06-14
Roche Cobas Connection Module Recalled for Vibration and Contamination Risk
Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.
Product
Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2242-2017·2017-06-14
ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks
ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.
Product
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2239-2017·2017-06-14
ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect
ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.
Product
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2250-2017·2017-06-14
Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect
Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.
Product
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2017·2017-06-14
ConvaTec Recalls Rebreathing Masks with Reservoir Bags and Tubing
ConvaTec, Inc. is voluntarily recalling Rebreathing Masks, Reservoir bags, with Tubing (Product Code 104MM) due to a Class II safety concern.
Product
Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2280-2017·2017-06-14
Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk
Arrow International is recalling Pressure Injectable PICC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2306-2017·2017-06-14
Arrow International Recalls Two-Lumen Hemodialysis Catheterization Kits
Arrow International Inc is recalling specific lots of two-lumen hemodialysis catheterization kits due to a Class II medical device recall.
Product
Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2238-2017·2017-06-14
ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns
ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.
Product
Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2249-2017·2017-06-14
Alphatec Recalls Arsenal Spinal Fixation System Set Screws
Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.
Product
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2236-2017·2017-06-14
ConvaTec Recalls Rebreather Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.
Product
Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2237-2017·2017-06-14
ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks
ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.
Product
Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2230-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2235-2017·2017-06-14
ConvaTec Recalls Elongated Oxygen Masks Due to Class II Safety Concerns
ConvaTec is voluntarily recalling specific lots of elongated oxygen masks. The FDA classified this as a Class II recall, indicating a reasonable probability of temporary adverse health consequences.
Product
Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2263-2017·2017-06-14
Arrow Central Venous Catheter Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of ARROWg+ard Blue PLUS Two-Lumen Central Venous Catheterization Kits due to safety cover disengagement and needlestick injury reports.
Product
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2227-2017·2017-06-14
Zimmer CAS Recalls Sesamoid Plasty Workstations Due to Structural Instability
Zimmer CAS is voluntarily recalling 10 Sesamoid Plasty workstations because the top of the unit may fall over during disassembly.
Product
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2247-2017·2017-06-14
Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect
Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.
Product
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2314-2017·2017-06-14
Cook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions
Cook Medical is voluntarily recalling LapSac Introducers because the reprocessing instructions do not provide sufficient detailed information for cleaning, disinfection, and sterilization.
Product
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2313-2017·2017-06-14
Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies
Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.
Product
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2307-2017·2017-06-14
Arrow International Recalls Hemodialysis Catheterization Kits
Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.
Product
ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
Category
Medical Device
Distribution
Distributed nationwide

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26576–26600 of 40233