Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 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 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
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 415 of 819
Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
Maquet Cardiovascular, LLC
Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
Maquet Cardiovascular, LLC
Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209
Maquet Cardiovascular, LLC
Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
Maquet Cardiovascular, LLC
Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008
Maquet Cardiovascular, LLC
Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
Maquet Cardiovascular, LLC
Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack
Maquet Cardiovascular, LLC
Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
Maquet Cardiovascular, LLC
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Terumo Medical Corporation
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps…
PF Consumer Healthcare 1 LLC
Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
Maquet Cardiovascular, LLC
Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32…
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
Maquet Cardiovascular, LLC
Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142
Maquet Cardiovascular, LLC
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove…
K2M, Inc
Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834
Maquet Cardiovascular, LLC
Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 30300 Material:701052623
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
Maquet Cardiovascular, LLC
Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668
Maquet Cardiovascular, LLC
Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
Maquet Cardiovascular, LLC
RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
Teleflex Medical
Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266
Maquet Cardiovascular, LLC
V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
Zimmer GmbH
Drill, contra-angle, 1.5x85mm, Item Number ST502015706
Zimmer GmbH
Drill, cannulated, 3x90mm, AO, Item Number ST502015631
Zimmer GmbH
Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G1483…
Cook Inc.
CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
Zimmer GmbH
Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
Zimmer GmbH
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a …
Boston Scientific Corporation
Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultiva…
Remel Inc
Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
Zimmer GmbH
UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 80…
Beckman Coulter Inc.
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
Zimmer GmbH
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
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC 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 Jul 29, 2026.