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Browse Device Recalls

813 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 813 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 813 FDA device recalls in PR.

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DateProductReasonClassFirm
May 20, 2014 ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURG... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARG... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS RE... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CAR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10)... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSOR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOC... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed Femoral Pack , convenience pack include multiple components: Syringe... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Customed O.B. Pack convenience pack include multiple components: set up cov... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAF... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APP... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REI... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICA... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TR... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CU... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAN... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9"... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) C... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, 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.