Browse Device Recalls
982 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 982 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 982 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 28, 2014 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... | Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... | Class II | Baxter Healthcare Corporation |
| Mar 25, 2014 | IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the managem... | Potential for microbial contamination of the product. | Class I | Wellspring Pharmaceutical Corporation |
| Feb 6, 2014 | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (A... | Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) be... | Class II | Philips Medical Systems North America Inc. |
| Jan 24, 2014 | Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packa... | The product may contain high levels of microbial contamination | Class II | Remel Inc |
| Nov 4, 2013 | Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap;... | There is a potential that the specified mucus specimen traps are not sterile. Use of the affected... | Class II | Medline Industries Inc |
| Sep 4, 2013 | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... | Class II | Baxter Healthcare Corp. |
| Aug 29, 2013 | DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Pro... | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 29, 2013 | DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 ... | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Jul 30, 2013 | Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product U... | Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series e... | Class II | Getinge Disinfection |
| Jul 19, 2013 | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile... | Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system durin... | Class II | Blue Belt Technologies MN |
| Jun 11, 2013 | Sodium Bicarbonate, USP Provided bulk as raw material - label not applicabl... | Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Ol... | Class II | Church & Dwight Inc |
| May 23, 2013 | Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 23, 2013 | Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... | Based on an accelerated aging test for this product packaging, there is an indicator of potential... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 15, 2013 | IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model I... | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2013 | IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da ... | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information... | Class II | Intuitive Surgical, Inc. |
| Feb 11, 2013 | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC My... | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL... | Class II | Microbiologics Inc |
| Feb 8, 2013 | Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part ... | Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a s... | Class II | Zimmer, Inc. |
| Jan 29, 2013 | Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide... | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross m... | Class II | Vascular Solutions, Inc. |
| Dec 31, 2012 | Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T... | RhMK product fungal contamination. | Class III | Diagnostic Hybrids Inc |
| Nov 13, 2012 | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu... | The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the ... | Class II | Leica Microsystems, Inc. |
| Nov 5, 2012 | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardia... | The seal between the white polyethylene and the clear plastic may be missing on the Hand Controll... | Class II | Medrad Inc |
| Oct 10, 2012 | The product is a lyophilized growth supplement for use with dehydrated cultur... | The product may contain low level microbial contamination which could result in incorrect results. | Class II | Remel 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.