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

35176–35200 of 40449

HighFDA (Devices)·Z-2296-2014·2014-08-27
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.
Product
Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2014·2014-08-27
Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error
Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.
Product
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2014·2014-08-27
ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals
ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2014·2014-08-27
Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects
Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.
Product
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2289-2014·2014-08-27
Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk
Zimmer, Inc. is recalling 190 units of Persona Tibial General Instrument Trays because incorrect bracket geometry may prevent proper sterilization of surgical instruments.
Product
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2238-2014·2014-08-27
Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results
Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.
Product
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2014·2014-08-27
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.
Product
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2014·2014-08-27
Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.
Product
PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2300-2014·2014-08-27
Zimmer Recalls Persona Knee Trial Components Due to Breakage Complaints
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.
Product
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2014·2014-08-27
AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error
AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.
Product
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2241-2014·2014-08-27
FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining
Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.
Product
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2245-2014·2014-08-27
Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.
Product
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2259-2014·2014-08-27
Medtronic Recalls Six Activa PC Implantable Neurostimulators
Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.
Product
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2252-2014·2014-08-27
Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues
Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.
Product
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2293-2014·2014-08-27
ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues
ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.
Product
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2014·2014-08-27
Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk
Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.
Product
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2290-2014·2014-08-27
Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk
Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.
Product
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2298-2014·2014-08-27
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.
Product
Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2270-2014·2014-08-27
Invivo Recalls Philips IP5 MRI Patient Monitoring Devices
Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.
Product
Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2246-2014·2014-08-27
Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
Product
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2301-2014·2014-08-27
Zimmer Recalls Persona Knee System Trial Components Due to Breakage
Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.
Product
Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2299-2014·2014-08-27
Zimmer Recalls Persona Knee Trial Articular Surface Provisionals
Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.
Product
Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2014·2014-08-27
Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.
Product
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2250-2014·2014-08-27
Zimmer Recalls 4.5 mm Malleolar Screws Due to Leak Test Failures
Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.
Product
4.5 mm Malleolar Screw Sterile zimmer
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2266-2014·2014-08-27
Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.
Product
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Category
Medical Device
Distribution
Distributed nationwide

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35176–35200 of 40449