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

26676–26700 of 40357

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
ModerateFDA (Devices)·Z-2319-2017·2017-06-14
Nexstim eXima NBS System Software Recalled for File Duplication Defect
Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.
Product
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2310-2017·2017-06-14
Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2220-2017·2017-06-14
Iba Dosimetry Recalls Large Stealth Chamber Dosimeters for Measurement Deviations
Iba Dosimetry is recalling 110 Large Stealth Chambers because they may show measurement deviations and geometric shadowing when used as reference detectors.
Product
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2311-2017·2017-06-14
Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2251-2017·2017-06-14
Teleflex Recalls Pediatric Nasal Cannulas Due to Incorrect Labeling
Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.
Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-2320-2017·2017-06-14
Nexstim Navigated Brain Stimulation System Software Defect Recall
Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.
Product
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2315-2017·2017-06-14
Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
Product
LapSac Introducer Set, Bag, Extraction, 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-2312-2017·2017-06-14
Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.
Product
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2309-2017·2017-06-14
Beekley Medical Mammography Skin Markers Recalled for Mislabeling
Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.
Product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2252-2017·2017-06-14
Argon Medical Recalls Arterial Access Needles Due to Packaging Defect
Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.
Product
Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2316-2017·2017-06-14
MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values
Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.
Product
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2221-2017·2017-06-14
Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling
Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.
Product
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-2151-2017·2017-06-07
Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates
Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.
Product
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2175-2017·2017-06-07
Philips NMT Patient Cable Recall for Potential Skin Burn Risk
Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.
Product
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Category
Medical Device
Distribution
31 states

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26676–26700 of 40357