The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

44951–44975 of 50512

  • HighFDA (Devices)·Z-2387-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.

    Product
    Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2012·2012-09-26

    Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws

    Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.

    Product
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2012·2012-09-26

    Biomet Recalls JuggerKnot In-Guide Punch Due to Knob Unfastening Risk

    Biomet is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch because the knob may unfasten and slide down the shaft during use.

    Product
    JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2420-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends

    Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2405-2012·2012-09-26

    Elekta Precise Digital Accelerator Recall Due to Loose Drive Gear Joint

    Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Precise Digital Accelerator Delivery of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1675-2012·2012-09-26

    Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

    Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

    Product
    ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2012·2012-09-26

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals

    Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.

    Product
    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2012·2012-09-26

    Philips Recalls MX 16-slice CT Scanners Due to Bolt Failure Risk

    Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2298-2012·2012-09-26

    Roundy's Rich Fields Butter Cookies Recalled for Bacillus cereus

    Atico International USA is recalling Roundy's Rich Fields Butter Cookies due to the presence of Toxigenic Bacillus cereus found in an FDA sample.

    Product
    Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2428-2012·2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.

    Product
    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2012·2012-09-26

    Smith & Nephew Recalls 70 Undersized Modular Hip Neck Components

    Smith & Nephew is recalling 70 modular hip neck components because the taper is undersized due to manufacturing errors.

    Product
    12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2321-2012·2012-09-26

    Organic Yerba Mate Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Organic Yerba Mate after inspectors found a pervasive mouse infestation in the facility.

    Product
    Organic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 500 CTS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2325-2012·2012-09-26

    Peppermint Leaf Organic C/S Recalled Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Peppermint Leaf Organic C/S because inspectors found a pervasive mouse infestation in the facility.

    Product
    Peppermint Leaf Organic C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2012·2012-09-26

    Varian Linear Accelerators Recalled Due to X-Jaw Carrier Alloy Defect

    Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.

    Product
    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2304-2012·2012-09-26

    Marigold Petals Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Marigold Petals Whole due to a pervasive mouse infestation found in the facility by CA inspectors.

    Product
    Marigold Petals Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2306-2012·2012-09-26

    Olive Leaf Organic Whole Recalled Due to Rodent Infestation

    San Francisco Herb & Natural Food Company is recalling Olive Leaf Organic Whole because inspectors found a pervasive mouse infestation in the facility.

    Product
    Olive Leaf Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2012·2012-09-26

    Zoe Medical Recalls Spacelabs Ultraview DM3 Monitors for Power Failure

    Zoe Medical Incorporated is recalling 35 Spacelabs Ultraview DM3 Monitors because they fail to power up, causing equipment alarms.

    Product
    Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2314-2012·2012-09-26

    Thyme Leaf Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Thyme Leaf C/S because inspectors found a pervasive mouse infestation in the facility.

    Product
    Thyme Leaf C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide