Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

2076–2100 of 2769

LowFDA (Devices)·Z-0547-2015·2014-12-17
Instrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
Instrumed International is withdrawing McKenzie enlarging burrs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0534-2015·2014-12-17
Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance
Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.
Product
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0550-2015·2014-12-17
Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss I
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0546-2015·2014-12-17
Instrumed Recalls D'errico Perforator Drills Due to Regulatory Non-Compliance
Instrumed International is withdrawing D'errico perforator drills because they do not meet FDA requirements for pre-amendment devices.
Product
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0538-2015·2014-12-17
Instrumed Recalls Mogen Circumcision Clamps for Regulatory Non-Compliance
Instrumed International is withdrawing 421 Mogen circumcision clamps because the company did not market these devices prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0545-2015·2014-12-17
Instrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
Instrumed International is withdrawing McKenzie Perforator Drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0554-2015·2014-12-17
Instrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
Instrumed International is withdrawing 17 traction tong replacement screws because they do not meet FDA requirements for pre-amendment devices.
Product
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0559-2015·2014-12-17
Instrumed Recalls Schoitz Weights for Regulatory Compliance Issues
Instrumed International is withdrawing Schoitz weights from the market because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (app
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0557-2015·2014-12-17
Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.
Product
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0289-2015·2014-12-10
Zydus Recalls Benzonatate Capsules Due to Foreign Capsule Contamination
Zydus Pharmaceuticals USA is recalling Benzonatate 200 mg capsules because they may contain foreign 100 mg capsules.
Product
BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0488-2015·2014-12-10
CooperSurgical Cannula-Curette Recalled for Incorrect Curette Type
CooperSurgical is recalling 30 units of the Cannula-Curette 12MM (Lot 147234) because the product contains an incorrect curette type.
Product
Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patient
Category
Medical Device
Distribution
3 states
LowFDA (Drugs)·D-0257-2015·2014-12-03
Zydus Recalls Amlodipine Besylate Tablets Due to Discoloration
Zydus Pharmaceuticals is recalling Amlodipine Besylate 10 mg tablets due to brown spots embedded in the product.
Product
AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0463-2015·2014-12-03
Abbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing
Abbott Molecular is recalling m2000sp CD-ROMs because some Application Specifications are incompatible with software versions 6.0 and 7.0, causing error code 9000.
Product
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0470-2015·2014-12-03
Novadaq Non-Sterile Drape Recalled for Incorrect Sterile Labeling
Novadaq Technologies is recalling 324 non-sterile LUNA drapes that were inadvertently mislabeled with an additional contents sterile label.
Product
Non-sterile drape
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0226-2015·2014-12-03
Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws
Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.
Product
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0469-2015·2014-12-03
Novadaq LUNA Chest Recalled for Sterile Labeling Error
Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.
Product
LUNA Chest, Model No. LU4006
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0505-2015·2014-11-26
Masiero Brothers Recalls Lemon Pound Cake for Misbranding
Masiero Brothers LLC is voluntarily recalling Oven Fresh Lemon Pound Cake due to misbranding. The product was distributed in New York.
Product
Oven Fresh Lemon Pound Cake, Net Wt. 5 oz., Oven Fresh Baking, LLC, 70 Clinton Road. Fairfield, NJ 07004, UPC 089595901145
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-0231-2015·2014-11-26
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration instead of 2 years.
Product
Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0232-2015·2014-11-26
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration period instead of the correct 2-year period.
Product
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0230-2015·2014-11-26
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.
Product
Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0229-2015·2014-11-26
Siemens Recalls ADVIA Centaur BNP Assay Reagents Due to Labeling Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP Assay reagents because approximately 2,000 ReadyPacks contain an incorrect human-readable side label.
Product
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (50
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0233-2015·2014-11-26
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration date instead of the correct 2-year date.
Product
Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0234-2015·2014-11-26
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration instead of the correct 2-year period.
Product
Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0254-2015·2014-11-26
Hospira Recalls Vancomycin Hydrochloride Vials Due to Mislabeling
Hospira Inc. is recalling 316,640 vials of Vancomycin Hydrochloride for Injection because product trays were mislabeled to contain a different product.
Product
VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0247-2015·2014-11-19
Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity Failure
Fresenius Kabi is recalling Haloperidol Decanoate Injection vials due to an out-of-specification impurity result. The recall covers 216,517 vials distributed nationwide and in Puerto Rico.
Product
HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
Category
Drug
Distribution
Distributed nationwide