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

40001–40025 of 40356

HighFDA (Devices)·Z-2178-2012·2012-08-15
Terumo Advanced Perfusion System 1 recalled for module malfunctions
Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.
Product
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2169-2012·2012-08-15
Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects
Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.
Product
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2161-2012·2012-08-15
Straumann Dental Implant Screw Recall Due to Incorrect Component
Straumann USA is recalling 14 dental implant sets because the included screw was not the correct Narrow CrossFit model.
Product
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2145-2012·2012-08-15
Smith & Nephew Dyonics Bonecutter Recalled for Incorrect Expiry Labeling
Smith & Nephew is recalling 108 units of the 5.5 mm Dyonics Bonecutter because the devices are labeled with a 48-month expiry instead of the validated 36-month period.
Product
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2147-2012·2012-08-15
ConMed Linvatec Recalls CrossFT Punch Due to Incorrect Etching
ConMed Linvatec is recalling 2 units of the CrossFT Punch (Lot #156920) because the device may have incorrect item numbers and depth lines.
Product
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2160-2012·2012-08-15
Afassco Multi-Colored Finger Cots Recalled for Missing Latex Warning Label
Afassco Inc. is voluntarily correcting a field issue for multi-colored finger cots that lack the required natural rubber latex warning label.
Product
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2143-2012·2012-08-15
SCC Soft Computer Recalls SoftLab Laboratory Information System Software
SCC Soft Computer is correcting SoftLab software versions that incorrectly displayed results from two different Sysmex hematology instruments under a single order.
Product
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2180-2012·2012-08-15
AngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches
AngioDynamics is recalling one lot of Soft-Vu angiographic catheters because a pouch inside the box may be mislabeled.
Product
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2162-2012·2012-08-15
Radiometer ABL800 Software Recall for HL7 Data Transmission Errors
Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.
Product
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2144-2012·2012-08-15
Smith & Nephew Dyonics Electroblade Resector Recalled for Labeling Error
Smith & Nephew is recalling Dyonics Electroblade Resectors labeled with an incorrect 48-month expiry date instead of 36 months.
Product
Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2156-2012·2012-08-15
Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure
Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.
Product
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2163-2012·2012-08-15
Radiometer ABL Software Recall for HL7 Data Transmission Errors
Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.
Product
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2146-2012·2012-08-15
Encore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws
Encore Medical is recalling 18 bone screws because the package label incorrectly states the size is 30mm, while the actual screw dimension is 25mm.
Product
djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2154-2012·2012-08-15
Greiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error
Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low test results.
Product
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2175-2012·2012-08-15
Siemens Recalls Dimension Vista Vancomycin Reagent Cartridges
Siemens is recalling Dimension Vista Vancomycin Reagent Cartridges because calibration failures prevent the vancomycin assay from running.
Product
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
Category
Medical Device
Distribution
39 states
LowFDA (Devices)·Z-2159-2012·2012-08-15
Roche Recalls Cobas KRAS Mutation Test Kits Due to Stability Concerns
Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.
Product
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2152-2012·2012-08-15
Impact Instrumentation Recalls Ten Model 731 EMV+ Uni-Vent Devices
Impact Instrumentation is recalling ten Model 731 EMV+ Uni-Vent devices shipped before verification of a new integrated circuit was completed.
Product
Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2148-2012·2012-08-15
Berchtold Chromovision HD Wireless Camera Recall for Loose Wire Connections
Berchtold Corp. is recalling 17 Chromovision HD Wireless Cameras because loose wire connections may cause image distortion or loss during surgical procedures.
Product
Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2012·2012-08-08
Sunrise Medical Recalls Padded Swing Away Arm Rests Due to Injury Reports
Sunrise Medical is recalling 14,035 Padded Swing Away Arm Rests for specific wheelchair models because reports indicate injury when the armrest is used to support full body weight.
Product
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2107-2012·2012-08-08
Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.
Product
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2092-2012·2012-08-08
Zimmer Recalls Nextgen Knee Replacement Jaw Instruments Due to Fracture Risk
Zimmer Inc. is recalling Nextgen Complete Knee Solution replacement jaws because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
Product
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2091-2012·2012-08-08
Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk
Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.
Product
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2012·2012-08-08
ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect
ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.
Product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2125-2012·2012-08-08
GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems
GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
Product
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2106-2012·2012-08-08
Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.
Product
ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide

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40001–40025 of 40356