Source
FDA Recalls
The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.
68,659Total Recalls
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
High RiskFDA
Zimmer, Inc.
90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx,...
Medical Devices192,355 affectedJun 7, 2013
High RiskFDA
Zimmer, Inc.
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX P...
Medical Devices192,355 affectedJun 7, 2013
High RiskFDA
Zimmer, Inc.
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Steril...
Medical Devices192,355 affectedJun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices30 affectedJun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Medical Devices3,255,096 affectedJun 7, 2013
High RiskFDA
Zimmer, Inc.
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthropl...
Medical Devices192,355 affectedJun 7, 2013
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 Devices192,355 affectedJun 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 Devices25 affectedJun 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 Devices24 affectedJun 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 Devices26 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Medical Devices3,255,096 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 7, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) ...
Medical Implants2 affectedJun 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 Devices22 affectedJun 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 Devices23 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices28 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 7, 2013
CriticalFDA
Medtronic Minimed
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Diabetes Devices11,000,000 affectedJun 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 Devices25 affectedJun 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 Devices31 affectedJun 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 Devices192,355 affectedJun 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 Devices22 affectedJun 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 Devices26 affectedJun 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 Devices1,912 affectedJun 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 Devices192,355 affectedJun 7, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx ...
Cardiac Devices93 affectedJun 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 Devices192,355 affectedJun 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 Devices25 affectedJun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Medical Devices3,255,096 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur ...
Medical Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices20 affectedJun 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 Devices46 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 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 Devices192,355 affectedJun 7, 2013