Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FAST Procedure Kit American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due… Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kansas, Massachusetts, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall The Constellation Vision System Pneumatic Handpiece Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLEXSTENT Biliary Self-Expanding Stent System Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall FLEXSTENT Femoropopliteal Self-Expanding Stent System Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall FLEXSTENT Biliary Self-Expanding Stent System Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall FLEXSTENT Femoropopliteal Self-Expanding Stent System Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall FLEXSTENT Femoropopliteal Self-Expanding Stent System Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur iPTH Calibrator 2 pk iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ iPTH Calibrator 6 pk iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Optisurgical’s TX1 Tissue Removal System Console The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall lnvatec SpA brand Diver C.E. Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZ Breathe Atomizer Possible dislodgement of the “Plate A”, if this instance occurs, it presents a potential choking hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 5, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall AsthmaNefrin Starter Kit contains ten Possible dislodgement of the “Plate A”, if this instance occurs, it presents a potential choking hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 5, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall EZ Breathe Medication Cup Possible dislodgement of the “Plate A”, if this instance occurs, it presents a potential choking hazard. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 5, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall QuietCare-Networked Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual… Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm Zimmer is initiating a lot specific recall of the Trabecular Metal” Tibia Stop Drill due to the potential of the outside diameter being oversized. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***REF S-3D*** 3mm Diamond Ball Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm,… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type Stem… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 Short… The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and… Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, Nevada, Texas and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System,… There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System,… There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System,… There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System,… There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8” There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. Class IIFDA’s classJun 5, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 5, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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