Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 32 of 63
Measurement Specialties Inc
Class II Ongoing
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to cont...
Reason: The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.
Z-0395-2018 January 31, 2018 Andover, MN
Repro-Med Systems, Inc.
Class II Terminated
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS6...
Reason: On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual de...
Z-0318-2018 January 17, 2018 Chester, NY
Repro-Med Systems, Inc.
Class II Terminated
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Reason: On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual de...
Z-0317-2018 January 17, 2018 Chester, NY
Medline Industries Inc
Class II Terminated
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Reason: Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Z-0295-2018 January 3, 2018 Northfield, IL
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially a...
Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide free...
Z-0185-2018 December 6, 2017 Westlake Village, CA
Medline Industries Inc
Class II Terminated
MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Reason: Products labeled as sterile were distributed prior to sterilization
Z-0112-2018 November 29, 2017 Northfield, IL
Medline Industries Inc
Class II Terminated
MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
Reason: Products labeled as sterile were distributed prior to sterilization
Z-0113-2018 November 29, 2017 Northfield, IL
Xintec Corp
Class II Terminated
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical pr...
Reason: It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed ...
Z-2866-2017 August 9, 2017 Alameda, CA
O-Two Medical Technologies, Inc.
Class II Terminated
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ prod...
Reason: For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o...
Z-2731-2017 July 19, 2017 Mississauga
Cook Inc.
Class II Terminated
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason: Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reproces...
Z-2540-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Clarke-Reich Laparoscopic Knot Pusher
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2537-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Endoscopic Introducer/Extractor
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2538-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary ...
Reason: Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficien...
Z-2585-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Stamey Needle
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2536-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Pereyra-Raz Ligature Carrier
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2534-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason: Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and ster...
Z-2539-2017 June 21, 2017 Bloomington, IN
Applied Medical Resources Corp
Class II Terminated
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Reason: Due to possibility of insufficient sterilization.
Z-2533-2017 June 21, 2017 Rancho Santa Margarita, CA
Cook Inc.
Class II Terminated
Pereyra Ligature Carrier 75
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Z-2535-2017 June 21, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2314-2017 June 14, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2311-2017 June 14, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2310-2017 June 14, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2315-2017 June 14, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic pro...
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2313-2017 June 14, 2017 Bloomington, IN
Cook Inc.
Class II Terminated
Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti...
Z-2312-2017 June 14, 2017 Bloomington, IN
Zimmer Biomet, Inc.
Class II Terminated
Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then pl...
Reason: Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two piec...
Z-2216-2017 June 7, 2017 Warsaw, IN