Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer, Inc.
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·25 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·24 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, S...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Fem...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 005...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Ste...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 1...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·28 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·25 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·31 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber ...
Medical Devices·1,912 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Ste...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Ste...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·25 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, R...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, R...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 0...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, R...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·20 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·46 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 F...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 0059720...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Steri...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Li...
Medical Devices·601,230 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Steri...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; ...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in t...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013