Sterilmed Inc
Osseo, MN
This page shows every FDA and USDA recall linked to Sterilmed Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
32
Total Recalls
2008
First Recall
2009
Most Recent
External Fixation Device
Model #'s:
ORT99-36501
SYN390.005
SYN390.008
SYN394.84
SYN394.85 and
SYN394.86
Inten...
Jan 13, 2009
· Device
Terminated
EP Catheter
Model #'s:
BIOD6-DR-005-RT
BIOD6-DR-010-RT
DAI401381
DAI401449
DAI401904
DAI401915 and
EPT7003D...
Jan 13, 2009
· Device
Terminated
Compression Sleeves
Model #'s:
HUNDVT10-1 and
KEN5329
The SterilMed Intermittent Compression Sleeve, 400 ser...
Jan 13, 2009
· Device
Terminated
Bed Check
Model #'s:
BED65815-021
BED65815-025
BED65815-025IT
BED65815-030
BED65815-031
BED73000
BED73010
BED...
Jan 13, 2009
· Device
Terminated
Retractors
Model #'s:
ADE3204
BOS820-175
LON3304 and
LON3334-4G
A manual surgical instrument for general use...
Jan 13, 2009
· Device
Terminated
Burrs
Model #'s:
ANSL-3SB
ANSL-5D
ANSQD11-4OVDC
HAL5056-118
HAL5056-166
HAL5091-106
HAL5091-112
HAL5091-122...
Jan 13, 2009
· Device
Terminated
Guidewires - Endoscopic (Jag Wires)
Model #'s:
MIC5658 and
MIC630-100
Intended to be used for selective can...
Jan 13, 2009
· Device
Terminated
Stone Retrieval Basket Model #': BOS390-105
Used to entrap and remove renal stones and calculi via a rig id or...
Jan 13, 2009
· Device
Terminated
Multi-Clip Applier
Model #'s:
APPCA080
AUT134031
AUT134046
AUT134051
AUT134053
AUT176625
AUT176657
AUTPTACK30...
Jan 13, 2009
· Device
Terminated
Tourniquet Cuffs
Model #'s:
INSDT-7024-02
INSDT-7218-01
SMI553322
SMI7010-7002
SMI7010-7006
SMI7010-7007
SMI7...
Jan 13, 2009
· Device
Terminated
Harmonic Scalpel
Model #'s:
ETHACE14S
ETHACE23P
ETHACE36P
ETHCS14C
ETHFCS9
ETHHDH05
ETHLCS-C5 and
ETHLCSC5H...
Jan 13, 2009
· Device
Terminated
Femoral Compression Device
Model #'s:
RAD11163
Intended for use in the compression of the femoral artery o...
Jan 13, 2009
· Device
Terminated
Saw Blade
Model #'s:
BIO506112
BIO506113
DEP2555-91-000
DEP5627-11-500
HAL5023-118
HAL5059-32
HAL5071-133
HAL...
Jan 13, 2009
· Device
Terminated
Rasps
Model #'s:
KOMKM5100-37-113
KOMKM-82
STR1675-115
STR5100-37-113 and
STR5100-37-115
A manual surgica...
Jan 13, 2009
· Device
Terminated
Lap Instruments/Graspers/Forceps - HOT
Model #'s:
AUT173016
AUT174301
AUT176643
AUT176643
ETH5DCD
ETH5DCS
ETH...
Jan 13, 2009
· Device
Terminated
Balloon Inflation Device
Model #'s:
MED15-105
MED15-106 and
SCI04527-01
The reprocessed Balloon inflation...
Jan 13, 2009
· Device
Terminated
Laser Probe Model #': SYN55.26.25
Reprocessed laser probes are part of a laser delivery system and are used in...
Jan 13, 2009
· Device
Terminated
Lap Instruments/Graspers/Forceps - COLD
Model #'s:
AUT173030
AUT174233
AUT174317
AUT176613
AUT176647
AUTECAT...
Jan 13, 2009
· Device
Terminated
Taps
Model #'s:
SYN311.15
SYN311.190
SYN311.39 and
SYN311.32
An orthopedic manual surgical instrument is a no...
Jan 13, 2009
· Device
Terminated
Reamers
Model #'s:
HAL5091-144 and
ZIMS5979-95-41
An orthopedic manual surgical instrument is a nonpowered ha...
Jan 13, 2009
· Device
Terminated
Biopsy Forceps, Hot
Model #'s:
BAL60110
BAR000852
BAR000854 and
MIC1550
Laparoscopic electric instruments are...
Jan 13, 2009
· Device
Terminated
RF Arthroscopy Probe
Model #'s:
ARTA1325-01
ARTA1335-01
ARTA1345-01
ARTA1730-01
ARTA2630-01
ARTA3625-01
ART...
Jan 13, 2009
· Device
Terminated
Biopsy Forceps, Cold
Model #'s:
BAR000386
BAR000388
MIC1012
MIC1331
MIC1333
MIC1337
MIC1536
MIC1589
MIC1597
M...
Jan 13, 2009
· Device
Terminated
Scissor Tips
Model #'s:
AESPO888
AESPO889
ENCES0102
MIC3112
MIC3122
MIC3142
MIC3152
SNO89-5100 and
SNO89-530...
Jan 13, 2009
· Device
Terminated
Phaco Tips
Model #'s:
ALC30RTS
ALC8065740806
ALC8065740809
ALC8065740837
ALC8065740839
ALC8065750852
ALC8065...
Jan 13, 2009
· Device
Terminated
Drill Bits
Model #'s:
DEP14043
MIC8053-019
RIC21-0438
RIC21-0439
RIC21-0441
RIC21-0442
RIC71173504
RIC7117350...
Jan 13, 2009
· Device
Terminated
Masks - Laryngeal
Model #'s:
AMB321-300-000
AMB321-400-000
AMB321-500-000
LMA12015
LMA12020
LMA12030
LMA12040...
Jan 13, 2009
· Device
Terminated
Colorado Electrodes
Model #'s:
COLN104A
COLN112A and
STRN103A
Intended for precision cutting or dissecting...
Jan 13, 2009
· Device
Terminated
EP Cables
Model #'s:
BAR560004P
BIOC10MR10MSTKS
BIOC5-MH/NAVMH-S
CORC6-MR10/EPTR-S
DAI401972
DAI401976
DAI40...
Jan 13, 2009
· Device
Terminated
Cardiac Imaging Catheter
Model #'s:
ACU08267996 and
ACU55790
Intended for intravascular or intracardiac ultra...
Jan 13, 2009
· Device
Terminated
TURP Electrodes
Model #'s:
CIRMLE-24-012
CIRMLE-24-015
OLYA22205C
STO27050F
STO27050G and
STO27050NK
Reproces...
Jan 13, 2009
· Device
Terminated
Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not...
Jan 13, 2009
· Device
Terminated