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.

2051–2075 of 2769

LowFDA (Devices)·Z-0732-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) por
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0826-2015·2014-12-24
Teleflex Recalls Weck Hemoclip Ligating Clips Due to Labeling Error
Teleflex Medical is recalling 3,180 units of Weck Hemoclip Ligating Clips because manufacturing and expiration dates were transposed on the packaging labels.
Product
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0302-2015·2014-12-24
Eisai Recalls Belviq Tablets Due to Missing or Illegible Labels
Eisai Inc. is recalling 121,680 bottles of Belviq (Lorcaserin HCl) 10 mg tablets because some bottles may lack labels or have illegible lot and expiry dates.
Product
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0662-2015·2014-12-24
Stryker Endoscopy Recalls 8mm Trocars Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 8mm trocars because the instructions for use do not support specific sterilization methods.
Product
PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0609-2015·2014-12-24
Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, HOOK SCISSORS, P/N 0250080020. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0660-2015·2014-12-24
Stryker Myoma Drill Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports w
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0782-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency
Category
Medical Device
Distribution
Distributed nationwide
LowUSDA FSIS·088-2014·2014-12-23
DaBecca Sliced Uncured Apple Smoked Bacon Recalled for Misbranding
DaBecca is recalling approximately 3,450 pounds of sliced uncured apple smoked bacon because the labels lacked the USDA mark of inspection.
Product
DaBecca LLC — Recall Notification Report 088-2014 (DaBecca Sliced Uncured Apple Smoked Bacon)
Category
Food
Distribution
2 states
LowUSDA FSIS·086-2014·2014-12-22
Abe's Finest Meats Recalls Hickory Smoked Sliced Bacon for Misbranding
Abe's Finest Meats is recalling approximately 80,050 pounds of hickory smoked sliced bacon because the ingredient sodium nitrite is not declared on the label.
Product
Recall Notification Report 086-2014 (Hickory Smoked Sliced Bacon)
Category
Food
Distribution
2 states
LowFDA (Devices)·Z-0535-2015·2014-12-17
Instrumed Recalls Surgical Trocars Due to Regulatory Non-Compliance
Instrumed International is withdrawing 11 surgical trocars because they do not meet FDA requirements for pre-amendment devices.
Product
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0540-2015·2014-12-17
Instrumed Recalls Hudson Braces for Regulatory Compliance Issues
Instrumed International is withdrawing Hudson braces from the market because the devices do not meet FDA requirements for pre-amendment status.
Product
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0552-2015·2014-12-17
Instrumed Recalls Lock Nuts for Titanium Traction Tongs
Instrumed International is withdrawing 49 lock nuts for titanium traction tongs because the devices were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Lock nuts for titanium traction tongs 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, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0551-2015·2014-12-17
Instrumed Recalls Non-Springloaded Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 67 replacement screw non-springloaded traction tongs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.
Product
Replacement screw non-springloaded 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 CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical bran
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0558-2015·2014-12-17
Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance
Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Tonometers are manual devices 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 (applying a small flat disk to the cornea) and
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0537-2015·2014-12-17
Instrumed Recalls Manual Bunnell Cranial Drills for Regulatory Non-Compliance
Instrumed International is withdrawing 13 manual Bunnell cranial drills because the company did not market them before 1976, failing FDA pre-amendment requirements.
Product
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0544-2015·2014-12-17
Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance
Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does not meet FDA requirements for Pre-Amendment devices.
Product
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0549-2015·2014-12-17
Instrumed Recalls Galt Trephines for Regulatory Compliance Issues
Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0553-2015·2014-12-17
Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues
Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.
Product
Titanium fixation screws, 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 Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand name
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0556-2015·2014-12-17
Instrumed Recalls CVB Distraction Screws Due to Regulatory Non-Compliance
Instrumed International is withdrawing 790 CVB distraction screws because the devices were not marketed before 1976, failing FDA pre-amendment requirements.
Product
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Telef
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0542-2015·2014-12-17
Instrumed Recalls Cushing Perforating Drills for Regulatory Non-Compliance
Instrumed International is withdrawing nine Cushing perforating drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0555-2015·2014-12-17
Gardner-Wells wrenches withdrawn for pre-amendment regulatory non-compliance
Instrumed International is withdrawing Gardner-Wells wrenches because they were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0541-2015·2014-12-17
Hudson cerebellar extensions recalled for pre-amendment marketing status issues
Instrumed International is withdrawing Hudson cerebellar extensions because they were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0533-2015·2014-12-17
Instrumed Recalls Endometrial Suction Curettes Due to Regulatory Non-Compliance
Instrumed International is withdrawing 26 endometrial suction curettes because the devices were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.
Product
An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include cathet
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0548-2015·2014-12-17
Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance
Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.
Product
Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0291-2015·2014-12-17
Sandoz Recalls Fluoxetine Capsules Due to Illegible Logo
Sandoz Inc. is recalling one lot of Fluoxetine Capsules because the logo on the capsules is illegible.
Product
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Category
Drug
Distribution
1 state