Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Omm Imports, Inc. Dba Zero Gravity
Recreo Hair Growth Laser Comb
Medical Devices·1,620 affected·Sep 1, 2022
High RiskFDA
Micro-x Ltd.
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Medical Devices·42 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929
Medical Devices·3 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
Medical Devices·38 affected·Aug 31, 2022
High RiskFDA
Full Vision Inc
FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
Medical Devices·69 affected·Aug 31, 2022
High RiskFDA
Philips Medical Systems (cleveland) Inc
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Medical Devices·169 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Medical Devices·373 affected·Aug 30, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Medical Devices·10,201 affected·Aug 30, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Medical Devices·164 affected·Aug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medica...
Medical Devices·355 affected·Aug 29, 2022
CriticalFDA
Teleflex Llc
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in bre...
Medical Devices·60,500 affected·Aug 29, 2022
High RiskFDA
Zimmer, Inc.
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Medical Devices·56 affected·Aug 25, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3...
Medical Devices·9,903 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-...
Medical Devices·25 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0...
Medical Devices·240 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Medical Devices·42 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09...
Medical Devices·488 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Medical Devices·115 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colos...
Medical Devices·3,209 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-...
Medical Devices·5,041 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a ...
Medical Devices·182 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH...
Medical Devices·204 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Medical Devices·58 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 ...
Medical Devices·150 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-CO...
Medical Devices·2,748 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Medical Devices·149 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-03...
Medical Devices·56 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Medical Devices·363 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 ...
Medical Devices·5,571 affected·Aug 16, 2022
High RiskFDA
Convatec, Inc
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a col...
Medical Devices·5,284 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Medical Devices·43 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-...
Medical Devices·1,236 affected·Aug 16, 2022
High RiskFDA
Cook Incorporated
Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
Medical Devices·0 affected·Aug 16, 2022
RecallFDA
Polymer Technology Systems, Inc. Dba Pts Diagnostics, Inc.
PTS Panels CHOL+GLU Test Strips (REF 1765)
Medical Devices·0 affected·Aug 16, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Medical Devices·1,306 affected·Aug 12, 2022
High RiskFDA
Coopersurgical, Inc.
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Medical Devices·5,182 affected·Aug 12, 2022
High RiskFDA
Coopersurgical, Inc.
Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no ...
Medical Devices·5,182 affected·Aug 12, 2022
High RiskFDA
Saranas, Inc.
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Medical Devices·953 affected·Aug 10, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Medical Devices·1,389 affected·Aug 10, 2022
RecallFDA
Steris Corporation Hopkins Facility
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging te...
Medical Devices·619 affected·Aug 10, 2022
CriticalFDA
Dewei Medical Equipment Co Ltd
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Medical Devices·1,348,000 affected·Aug 9, 2022
CriticalFDA
Technomed Europe
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Medical Devices·37 affected·Aug 9, 2022
CriticalFDA
Baxter Healthcare Corporation
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Medical Devices·511,728 affected·Aug 9, 2022
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Medical Devices·88 affected·Aug 8, 2022
High RiskFDA
Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytopla...
Medical Devices·1,336 affected·Aug 3, 2022
High RiskFDA
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CO...
Medical Devices·1,822 affected·Aug 3, 2022