Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 33 of 63
Molnlycke Health Care, Inc
Class II Ongoing
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Reason: Sterilization validation failure.
Z-2110-2017 May 24, 2017 Norcross, GA
Breg Inc
Class II Terminated
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings a...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1908-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically a...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1902-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically a...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1903-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1906-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typical...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1901-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typical...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1904-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically ap...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1905-2017 May 10, 2017 Carlsbad, CA
Breg Inc
Class II Terminated
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically app...
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Z-1907-2017 May 10, 2017 Carlsbad, CA
Signal Medical Corporation
Class II Terminated
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Reason: Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip mus...
Z-1834-2017 April 26, 2017 Marysville, MI
Devicor Medical Products Inc
Class II Terminated
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Reason: The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Z-1512-2017 March 29, 2017 Cincinnati, OH
Encore Medical, Lp
Class II Terminated
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilize...
Reason: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, wh...
Z-1191-2017 February 22, 2017 Austin, TX
Advanced Sterilization Products
Class II Terminated
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Reason: Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during...
Z-1197-2017 February 22, 2017 Irvine, CA
Mesa Laboratories Inc
Class II Terminated
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicato...
Reason: Product resistance has fallen outside of label claim within expiry.
Z-1104-2017 February 1, 2017 Omaha, NE
Symmetry Surgical, Inc.
Class II Terminated
symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-...
Reason: Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-ster...
Z-1012-2017 January 18, 2017 Antioch, TN
Acumed LLC
Class II Terminated
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Reason: OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not ...
Z-1019-2017 January 18, 2017 Hillsboro, OR
Advanced Sterilization Products
Class II Terminated
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant...
Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
Z-0965-2017 January 18, 2017 Irvine, CA
Symmetry Surgical, Inc.
Class II Terminated
symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C181...
Reason: Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-ster...
Z-1011-2017 January 18, 2017 Antioch, TN
Symmetry Surgical, Inc.
Class II Terminated
symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C241...
Reason: Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-ster...
Z-1010-2017 January 18, 2017 Antioch, TN
Zimmer Biomet, Inc.
Class II Terminated
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum seale...
Reason: Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package...
Z-0956-2017 January 18, 2017 Warsaw, IN
Trilliant Surgical Ltd.
Class II Terminated
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of...
Reason: Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 i...
Z-0960-2017 January 18, 2017 Houston, TX
MEDLINE IND
Class II Terminated
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therape...
Reason: Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
Z-0984-2017 January 18, 2017 Northfield, IL
Greatbatch Medical
Class I Terminated
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP...
Reason: On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using...
Z-0367-2017 December 7, 2016 Plymouth, MN
Stryker Instruments Div. of Stryker Corporation
Class III Terminated
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Reason: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use...
Z-0584-2017 November 23, 2016 Portage, MI
Akita Sumitomo Bakelite Co., Ltd.
Class II Terminated
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-4770...
Reason: Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
Z-0388-2017 November 16, 2016 Akita