PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
41,070
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 41,070 total recalls
  • #1 of 12 among categories
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
total recalls
#1 of 12
category rank by events
9%
graded high-severity
FDA Devices
top issuing agency

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

41,070 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-02

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Recalls in Medical Devices

Newest first · Page 708 of 822

FDA Devices Critical Sep 10, 2014

Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1" (2) S…

Customed, Inc

FDA Devices Critical Sep 10, 2014

OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDE…

Customed, Inc

FDA Devices Critical Sep 10, 2014

MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz…

Customed, Inc

FDA Devices Critical Sep 10, 2014

ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE …

Customed, Inc

FDA Devices Critical Sep 10, 2014

UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAING…

Customed, Inc

FDA Devices Critical Sep 10, 2014

UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT…

Customed, Inc

FDA Devices Critical Sep 10, 2014

HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 9…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPE…

Customed, Inc

FDA Devices Critical Sep 10, 2014

PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAPE TOP…

Customed, Inc

FDA Devices Critical Sep 10, 2014

DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ( I) DRESSING TEGADERM 3 Y2 X 4 Y2 ( I) MASK PROCEDURAL YELLOW 80MM HG …

Customed, Inc

FDA Devices Moderate Sep 10, 2014

Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Del…

Hill-Rom, Inc.

FDA Devices Critical Sep 10, 2014

CIRUGIA CARDIOVASCULAR - CASE CART - (1) CIRUGIA CARDIOVASCULAR (PREPARACION) (1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIO…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1)…

Customed, Inc

FDA Devices Moderate Sep 10, 2014

Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis…

Medical Components, Inc dba MedComp

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY CHOLECYSTECTOMY PACK - (1) SHEET LAPAROS/ABDOMINAL UF (1) MAYO STAND COVER REINFORCED UF (1) BLADE SURGICAL #11 STAINLESS STEEL (…

Customed, Inc

FDA Devices Critical Sep 10, 2014

O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS R…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK U…

Customed, Inc

FDA Devices Critical Sep 10, 2014

ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C …

Customed, Inc

FDA Devices Critical Sep 10, 2014

UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE …

Customed, Inc

FDA Devices Critical Sep 10, 2014

PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE …

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROTOMY BASIC PACK- CUSTOMED- (1) TABLE COVER REINFORCED 44" X 78" LIF (1) COVER MAYO STAND REINFORCED UF (2) TOWEL ABSORBENT 15" X 20" UF (1…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER S…

Customed, Inc

FDA Devices Moderate Sep 10, 2014

FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perf…

Elekta, Inc.

FDA Devices Critical Sep 10, 2014

Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUS…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER …

Customed, Inc

FDA Devices Critical Sep 10, 2014

NEURO PACK- (1)TABLE COVER 44" x 90" (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) BAG SUTURE FLORAL…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL …

Customed, Inc

FDA Devices Critical Sep 10, 2014

Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DR…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAP…

Customed, Inc

FDA Devices Critical Sep 10, 2014

ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. E…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLOTH HUCK BLUE LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COV…

Customed, Inc

FDA Devices Critical Sep 10, 2014

FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/pol…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glo…

Customed, Inc

FDA Devices Critical Sep 10, 2014

TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHf…

Customed, Inc

FDA Devices Critical Sep 10, 2014

PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID…

Customed, Inc

FDA Devices Critical Sep 10, 2014

C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PR…

Customed, Inc

FDA Devices Critical Sep 10, 2014

LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LA…

Customed, Inc

FDA Devices Critical Sep 10, 2014

Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 2…

Customed, Inc

FDA Devices Critical Sep 10, 2014

ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STO…

Customed, Inc

FDA Devices Critical Sep 10, 2014

CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WIT…

Customed, Inc

FDA Devices Critical Sep 10, 2014

GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) …

Customed, Inc

FDA Devices Critical Sep 10, 2014

Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table co…

Customed, Inc

FDA Devices Critical Sep 10, 2014

BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYR…

Customed, Inc

FDA Devices Critical Sep 10, 2014

PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10…

Customed, Inc

FDA Devices Critical Sep 10, 2014

NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FUL…

Customed, Inc

FDA Devices Critical Sep 10, 2014

NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X …

Customed, Inc

FDA Devices Critical Sep 10, 2014

General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) GOWN LARGE …

Customed, Inc

FDA Devices Critical Sep 10, 2014

ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAP…

Customed, Inc

What to do with this

Monitoring medical devices? Start here.

  • Check a specific product against the full federal archive before you use or buy it. Recall checker
  • Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
  • Sort the whole archive by severity to see the highest-risk active recalls first. Rankings

Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.

Nearby categories

Adjacent product categories that share hazard patterns or regulatory oversight.

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Aug 19, 2026.