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

29576–29600 of 40449

ModerateFDA (Devices)·Z-2316-2016·2016-08-10
Medtronic Navigation StealthStation Software Voluntary Field Action
Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2338-2016·2016-08-10
Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects
Zimmer Surgical Inc is recalling 60 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.
Product
Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2326-2016·2016-08-10
Mentor MemoryGel Breast Implant Recall Due to Missing Date Labels
Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.
Product
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2329-2016·2016-08-10
AccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors
AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.
Product
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2334-2016·2016-08-10
Zimmer Air Dermatome II Handpieces Recalled for Surface Coating Defects
Zimmer Surgical Inc is recalling 630 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.
Product
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2317-2016·2016-08-10
Medtronic Navigation Recalls Fusion ENT Software Application
Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.
Product
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2323-2016·2016-08-10
Zimmer Biomet Recalls V-Tek Twist Drills Due to Tolerance Issues
Zimmer Biomet is voluntarily recalling 169 V-Tek Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.
Product
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2302-2016·2016-08-10
Ortho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.
Product
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2320-2016·2016-08-10
Implant Direct Recalls RePlant Angled Abutments Due to Design Defect
Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.
Product
RePlant¿ Angled Abutment Part Number 6050-52-60
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-2318-2016·2016-08-10
Medtronic Navigation Recalls StealthStation Software Applications
Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2340-2016·2016-08-10
Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects
Zimmer Surgical Inc is recalling 110 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.
Product
Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2301-2016·2016-08-10
Merge PACS software recall for missing patient data in telmed studies
Merge Healthcare is recalling specific versions of Merge PACS software because studies received via telmed were missing patient DOB, procedure, and referring physician information.
Product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2322-2016·2016-08-10
Zimmer Biomet Recalls Twist Drills Due to Tolerance Issues
Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.
Product
TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2314-2016·2016-08-10
Medtronic Navigation Recalls StealthStation Software Applications
Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2315-2016·2016-08-10
Medtronic Navigation Recalls S7 MACH FrameLink Software Applications
Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Product
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2309-2016·2016-08-10
Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups
Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in short-circuits and instrument stop mode.
Product
AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2333-2016·2016-08-10
C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues
C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.
Product
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2327-2016·2016-08-10
Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels
Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.
Product
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip…
Category
Medical Device
Distribution
20 states
LowFDA (Devices)·Z-2311-2016·2016-08-10
Branan Medical Recalls AmediCheck Instant Test Cups Due to Packaging Error
Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.
Product
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2016·2016-08-03
Moller Vital Molift Air Ceiling Hoist Recall for Loose Bolt Risk
Moller Vital is recalling Molift Air ceiling hoists because the suspension coupling bolt may come loose, posing a risk of patient falls.
Product
Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2016·2016-08-03
Stryker Trident Constrained Liner Inserter Impactor Tip Recall
Stryker is recalling Trident Constrained Liner Inserter Impactor Tips because they do not meet required sterility assurance levels when steam sterilized.
Product
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2236-2016·2016-08-03
GE Phoenix v|tome|x m240 X-Ray Systems Recalled for Radiation Emissions
GE Inspection Technologies is recalling four Phoenix v|tome|x m240 cabinet x-ray systems because radiation emissions exceeded safety limits due to insufficient door shielding.
Product
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2212-2016·2016-08-03
BD Recalls Diamond-Flex Retractors Due to Weld Failure Risk
BD is recalling specific Diamond-Flex Circular Retractors because a weld failure could cause wire protrusion, potentially damaging tissue or organs during use.
Product
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2290-2016·2016-08-03
Sunrise Medical Recalls Quickie Q7 Wheelchairs Due to Backrest Bracket Failure
Sunrise Medical is recalling Quickie Q7 wheelchairs because the backrest bracket can fracture, causing the backrest to detach from the chair frame.
Product
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2293-2016·2016-08-03
Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors
Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.
Product
MOSAIQ Oncology Information System
Category
Medical Device
Distribution
Distributed nationwide

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29576–29600 of 40449