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

33751–33775 of 40449

ModerateFDA (Devices)·Z-0968-2015·2015-01-21
Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Error
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because software versions 3.1 and below may fail to identify expired calibrations.
Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0854-2015·2015-01-21
Siemens Artis zee/zeego Systems Recalled for X-Ray Tube Focal Spot Failure
Siemens Medical Solutions is recalling 44 Artis zee/zeego angiography systems because the small focus of the x-ray tube may fail, causing a short interruption in procedures.
Product
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0988-2015·2015-01-21
Ziemer Femto LDV Z-Generation Lasers Recalled for Missing Starter Kits
Ziemer USA Inc. is recalling 26 Femto LDV Z-Generation femtosecond surgical lasers because they were not shipped with the required Starter Kits.
Product
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0841-2015·2015-01-21
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Recall for Accuracy Issues
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because their accuracy may exceed the design specification of +10%.
Product
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0967-2015·2015-01-21
Ortho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems because software versions 3.1 and below may fail to identify expired calibrations.
Product
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2015·2015-01-21
Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects
Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.
Product
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0840-2015·2015-01-21
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Recall for Accuracy Deviation
GE OEC Medical Systems is recalling 61 mobile C-Arm X-ray units because the accuracy of the x-ray tube potential and current may exceed the manufacturer's specified limits.
Product
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0970-2015·2015-01-21
Stelkast Recalls EXp Tibial Inserts Due to Manufacturing Defect
Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.
Product
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous…
Category
Medical Device
Distribution
10 states
LowFDA (Devices)·Z-0990-2015·2015-01-21
Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors
Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they were manufactured 7cm shorter than specifications.
Product
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to…
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-0964-2015·2015-01-21
Mentor MemoryGel Resterilizable Gel Sizer Recalled for Incorrect Instructions
Mentor Texas, LP. is recalling 45 units of MENTOR MemoryGel Resterilizable Gel Sizers because they contain incorrect instructions for use.
Product
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
Category
Medical Device
Distribution
17 states
LowFDA (Devices)·Z-0991-2015·2015-01-21
Tecan Infinite 200 Microplate Reader Recalled for Incorrect Firmware Version
Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).
Product
Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0989-2015·2015-01-21
Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors
Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.
Product
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-0992-2015·2015-01-21
Tecan Infinite 200PRO Microplate Reader Recalled for Firmware Error
Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.
Product
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0905-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.
Product
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0880-2015·2015-01-14
Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system may provide INR results significantly lower than reference laboratory methods.
Product
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0903-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.
Product
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0904-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.
Product
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2015·2015-01-14
Trumpf Medical Systems Recalls JUPITER U Remote Controls for Unintended Movement
Trumpf Medical Systems is recalling JUPITER U remote controls because damaged units may cause unintended movement of operating tables during surgery.
Product
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-0881-2015·2015-01-14
Alere INRatio Monitors Recalled for Potential Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.
Product
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0882-2015·2015-01-14
Alere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.
Product
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2015·2015-01-14
DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk
DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.
Product
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0931-2015·2015-01-14
Synthes Small Electric Drive Recalled for Unintended Start and Malfunction
Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.
Product
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0923-2015·2015-01-14
Trumpf Medical Systems Recalls IIR Remote Controls for Operating Tables
Trumpf Medical Systems is recalling IIR remote controls for JUPITER operating tables due to reports of unintended movement during surgery.
Product
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-0924-2015·2015-01-14
Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement
Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables because complaints were reported of unintended movement during surgical cases.
Product
(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer…
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0922-2015·2015-01-14
Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement
Trumpf Medical Systems is recalling JUPITER remote controls for operating tables because damaged units may cause unintended movement during surgery.
Product
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient…
Category
Medical Device
Distribution
25 states

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33751–33775 of 40449