Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2014 | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) ... | Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at... | Class II | Bard Peripheral Vascular Inc |
| Aug 14, 2014 | Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ ... | Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unope... | Class II | Biomedix, Inc. |
| Aug 6, 2014 | B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices... | The primary packaging label (inner pouch label) indicates that the package contents are Catalog I... | Class II | B. Braun Medical, Inc. |
| Aug 5, 2014 | DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, ... | Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves... | Class II | Catheter Connections, Inc. |
| Aug 1, 2014 | CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STO... | A pinhole leak identified in the packaging of the recalled product potentially could compromise t... | Class II | Civco Medical Instruments Inc |
| Jul 22, 2014 | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105L... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG ... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLA... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MI... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FN... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 9, 2014 | Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscop... | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates ... | Class II | Teleflex Medical |
| Jul 1, 2014 | Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 2... | Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenest... | Class II | Zimmer, Inc. |
| Jun 25, 2014 | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a pol... | A potential splitting of the surface treatment of the thread ends on certain sutures has recently... | Class II | Peters Surgical |
| Jun 25, 2014 | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are compos... | A potential splitting of the surface treatment of the thread ends on certain sutures has recently... | Class II | Peters Surgical |
| Jun 20, 2014 | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Mode... | Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration | Class II | ORIGIO, Inc |
| Jun 17, 2014 | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... | Inadequate iodine and packaging related defects. | Class II | Baxter Healthcare Corp. |
| Jun 11, 2014 | Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... | Lack of Sterility Assurance | Class II | PIONEER SURGICAL TECHNOLOGY, INC. |
| Jun 6, 2014 | CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an en... | A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... | Class II | Becton Dickinson & Co. |
| Jun 6, 2014 | Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a g... | A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... | Class II | Becton Dickinson & Co. |
| Jun 6, 2014 | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar ... | A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... | Class II | Becton Dickinson & Co. |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory g... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas h... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respi... | The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentiall... | Class II | Teleflex Medical |
| Jun 5, 2014 | Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory ga... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory g... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humid... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humi... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas ... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| Jun 5, 2014 | Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respi... | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. | Class II | Teleflex Medical |
| May 20, 2014 | ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15"... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REI... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | 0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LITHOTOMY PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.